PHARMASEAL WOUND CARE DRESSING PAD— 510(k) K870941

Clearance details

Applicant

American Pharmaseal Div. Ahsc

Product code

Code KOZ

Device class

Class 1

Regulation

21 CFR 878.4018

Advisory panel

General, Plastic Surgery

Date received

1987-03-09

Decision date

1987-03-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Valencia, CA, US

• K905206 — INCARE PINSITE DRESSING1991-04-12
• K905688 — CUTINOVA HYDRO1991-04-01
• K905069 — IODOSORB GEL1991-01-31
• K904604 — REDI-RELEASE ABSORBENT DRESSING1991-01-07
• K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING1990-11-21

• K874022 — PHARMASEAL WOUND IRRIGATION DEVICE1987-12-30
• K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER1987-12-03
• K874517 — PHARMASEAL RUBBER URETHRAL CATHETER1987-12-03
• K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE1987-11-06
• K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM1987-09-04

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →