1/2 CM REAR TIP EXTENDER (RTE)— 510(k) K882297

Name: FDA 510(k) clearance K882297
Creator: U.S. Food and Drug Administration
Published: 1988-06-17

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K882297 for 1/2 CM REAR TIP EXTENDER (RTE), Substantially Equivalent on 1988-06-17. Applicant: American Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code FHN
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 1988-06-02
Decision date: 1988-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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