Medical Device Manufacturer · US , Dana Point , CA

Renaissance Medical, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1992

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Renaissance Medical, Inc. General & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Jan 18, 1994

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL

General & Plastic Surgery · 84d

Cleared Jan 10, 1994

ROYL-DERM WOUND HYDROGEL DRESSING

General & Plastic Surgery · 210d

Cleared Jan 10, 1994

ROYL-DERM WOUND HYDROGEL STERILE UNIT DOSE

General & Plastic Surgery · 159d

Cleared Oct 28, 1992

ROYL-DERM WOUND HYDROGEL

General & Plastic Surgery · 139d