BENDEREV PROTECT-A-PASS NEEDLE— 510(k) K921228

Name: FDA 510(k) clearance K921228
Creator: U.S. Food and Drug Administration
Published: 1992-09-14

Substantially Equivalent

Eimark Labs, Inc.

FDA 510(k) clearance K921228 for BENDEREV PROTECT-A-PASS NEEDLE, Substantially Equivalent on 1992-09-14. Applicant: Eimark Labs, Inc.. Device class: 1.

Clearance details

Applicant: Eimark Labs, Inc.
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1992-03-13
Decision date: 1992-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, US

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