IODOSORB GEL— 510(k) K905069

Name: FDA 510(k) clearance K905069
Creator: U.S. Food and Drug Administration
Published: 1991-01-31

Substantially Equivalent

Perstorp AB C/O Robert Joel Slomoff

FDA 510(k) clearance K905069 for IODOSORB GEL, Substantially Equivalent on 1991-01-31. Applicant: Perstorp AB C/O Robert Joel Slomoff. Device class: 1.

Clearance details

Applicant: Perstorp AB C/O Robert Joel Slomoff
Product code: Code KOZ
Device class: Class 1
Regulation: 21 CFR 878.4018
Advisory panel: General, Plastic Surgery
Date received: 1990-11-09
Decision date: 1991-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

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K905206 — INCARE PINSITE DRESSING1991-04-12
K905688 — CUTINOVA HYDRO1991-04-01
K904604 — REDI-RELEASE ABSORBENT DRESSING1991-01-07
K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING1990-11-21
K903645 — DERMASORB WOUND CONTACT LAYER DRESSING1990-11-21

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K870559 — IODOSORB POWDER1987-03-20

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.