IP-758 BURN WOUND DRESSING— 510(k) K810902

Substantially Equivalent

Exopack

FDA 510(k) clearance K810902 for IP-758 BURN WOUND DRESSING, Substantially Equivalent on 1981-09-11. Applicant: Exopack. Device class: 1.

Clearance details

Applicant: Exopack
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1981-04-03
Decision date: 1981-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NAE

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K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING1999-09-17
K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING1999-06-28

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