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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K921228
Device Name BENDEREV PROTECT-A-PASS NEEDLE
Applicant
Eimark Labs, Inc.
26732 Crown Valley Pkwy.
Suite 501
Mission Viejo,  CA  92691
Applicant Contact NEIL NAVES
Correspondent
Eimark Labs, Inc.
26732 Crown Valley Pkwy.
Suite 501
Mission Viejo,  CA  92691
Correspondent Contact NEIL NAVES
Regulation Number876.4730
Classification Product Code
KOA  
Date Received03/13/1992
Decision Date 09/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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