IMPOWER EXTERNAL VACUUM SYSTEM— 510(k) K980291

Name: FDA 510(k) clearance K980291
Creator: U.S. Food and Drug Administration
Published: 1998-03-11

Substantially Equivalent

Imagyn Medical Technologies, Inc.

FDA 510(k) clearance K980291 for IMPOWER EXTERNAL VACUUM SYSTEM, Substantially Equivalent on 1998-03-11. Applicant: Imagyn Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Imagyn Medical Technologies, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1998-01-26
Decision date: 1998-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

Download summary PDF View on FDA.gov ↗

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