AME PINSITE SHIELD(TM)— 510(k) K884798

Name: FDA 510(k) clearance K884798
Creator: U.S. Food and Drug Administration
Published: 1989-02-10

Substantially Equivalent

American Medical Electronics, Inc.

FDA 510(k) clearance K884798 for AME PINSITE SHIELD(TM), Substantially Equivalent on 1989-02-10. Applicant: American Medical Electronics, Inc.. Device class: 2.

Clearance details

Applicant: American Medical Electronics, Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1988-11-16
Decision date: 1989-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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