Medical Device Manufacturer · US , Fort Worth , TX

Prestige Ameritech - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2006

Recent clearances: ProGear® Surgical Mask with Oxafence®, Model AV82030, Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield, Prestige Ameritech Pediatric/Child’s Face mask

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Prestige Ameritech General Hospital ✕

5 devices

1-5 of 5

Cleared Sep 05, 2024

ProGear® Surgical Mask with Oxafence®, Model AV82030

General Hospital · 449d

Cleared Aug 15, 2017

Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face...

General Hospital · 117d

Cleared Oct 07, 2016

Prestige Ameritech Pediatric/Child’s Face mask

General Hospital · 262d

Cleared Oct 06, 2010

PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE...

General Hospital · 71d

Cleared Aug 14, 2006

PRESTIGE AMERITECH FACE MASK

General Hospital · 56d