ULTRACELL INSTRUMENT WIPE— 510(k) K920353

Name: FDA 510(k) clearance K920353
Creator: U.S. Food and Drug Administration
Published: 1992-09-15

Substantially Equivalent

Ultracell Medical Technologies, Inc.

FDA 510(k) clearance K920353 for ULTRACELL INSTRUMENT WIPE, Substantially Equivalent on 1992-09-15. Applicant: Ultracell Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ultracell Medical Technologies, Inc.
Product code: Code HEP
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 1992-01-27
Decision date: 1992-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Stonington, CT, US

Download summary PDF View on FDA.gov ↗

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