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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 K923512
Device Name OPERATING ROOM NEEDLE COUNTER
Applicant
Sharp-Trap, Inc.
15777 W. 10 Mile #200-100
Southfield,  MI  48075
Applicant Contact FREDERICK J SAWAYA
Correspondent
Sharp-Trap, Inc.
15777 W. 10 Mile #200-100
Southfield,  MI  48075
Correspondent Contact FREDERICK J SAWAYA
Regulation Number880.5570
Classification Product Code
MMK  
Date Received07/07/1992
Decision Date 11/23/1992
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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