PFM MEDICAL INCORPORATED 616.362.2080-A Tita Jet Light

HAWLEY FORM RETAINER

Tinted Pearlescent Powder

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Smart Port CT Low Profile Titanium Port System with Attachable 6.6F x 55cm Polyurethane Catheter and 7F Introducer Kit (Non-Filled Suture Holes)

PowerPort ClearVUE Slim Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Intermediate Kit

Smart Port CT Single Titanium Port System with Attachable 8.0F x 66cm Polyurethane Catheter and 8 F Introducer Kit (with Valved Introducer and Non-Filled Suture Holes)

Vaccess CT Low-Profile Power-Injectable Implantable Port 6F (with Suture Plugs) (6F)

Vortex LP Single Titanium Port System with Attachable 9.6F x 76cm Silicone Catheter

Fiberoptic Light Cable (Wolf Scope and Stryker Light Source Fittings, Snap-On)

HAWLEY FORM RETAINER

Tinted Pearlescent Powder

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.