EPITECH ISLAND DRESSINGS— 510(k) K971337

Substantially Equivalent

Rynel, Ltd. Inc.

FDA 510(k) clearance K971337 for EPITECH ISLAND DRESSINGS, Substantially Equivalent on 1997-07-09. Applicant: Rynel, Ltd. Inc.. Device class: 1.

Clearance details

Applicant: Rynel, Ltd. Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1997-04-10
Decision date: 1997-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boothbay, ME, US

Download summary PDF View on FDA.gov ↗

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