EXUSORB(TM) GEL DRESSING— 510(k) K895606

Name: FDA 510(k) clearance K895606
Creator: U.S. Food and Drug Administration
Published: 1989-10-19

Substantially Equivalent for Some Indications

Controlled Therapeutics Corp.

FDA 510(k) clearance K895606 for EXUSORB(TM) GEL DRESSING, Substantially Equivalent for Some Indications on 1989-10-19. Applicant: Controlled Therapeutics Corp.. Device class: 1.

Clearance details

Applicant: Controlled Therapeutics Corp.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1989-09-18
Decision date: 1989-10-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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K896176 — EXUSORB(TM) DRY/WET DRESSING1989-11-24
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K894274 — EXUSORB TRANSPARENT DRESSING1989-08-18

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