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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K915067
Device Name DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS
Applicant
American Medical Corp.
22231 Mulholland Hwy.
Woodland Hills,  CA  91364
Applicant Contact MIKE HOFTMAN
Correspondent
American Medical Corp.
22231 Mulholland Hwy.
Woodland Hills,  CA  91364
Correspondent Contact MIKE HOFTMAN
Regulation Number880.5570
Classification Product Code
MMK  
Date Received11/08/1991
Decision Date 03/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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