BIOCLUSIVE(R) ABSORBENT DRESSING— 510(k) K896828

Name: FDA 510(k) clearance K896828
Creator: U.S. Food and Drug Administration
Published: 1990-11-21

Substantially Equivalent

Johnson & Johnson International

FDA 510(k) clearance K896828 for BIOCLUSIVE(R) ABSORBENT DRESSING, Substantially Equivalent on 1990-11-21. Applicant: Johnson & Johnson International. Device class: 1.

Clearance details

Applicant: Johnson & Johnson International
Product code: Code KOZ
Device class: Class 1
Regulation: 21 CFR 878.4018
Advisory panel: General, Plastic Surgery
Date received: 1989-12-04
Decision date: 1990-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOZ

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K905206 — INCARE PINSITE DRESSING1991-04-12
K905688 — CUTINOVA HYDRO1991-04-01
K905069 — IODOSORB GEL1991-01-31
K904604 — REDI-RELEASE ABSORBENT DRESSING1991-01-07
K903645 — DERMASORB WOUND CONTACT LAYER DRESSING1990-11-21

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K944937 — SYNTHETIC ABSORBABLE SUTURE1995-05-19
K946245 — TIELLE* HYDROPOLYMER DRESSING1995-04-11
K942383 — DERMIVIEW CLEAR TAPE1994-08-22
K922918 — BARRIER SAF-TE HYDROGEL DRAPE1993-07-06

Adverse events under product code KOZ

product code KOZ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.