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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K870192
Device Name DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE
Applicant
Can-Am Surgical Corp.
3068 Stonewood St.
Simi Valley,  CA  93063
Applicant Contact COVER
Correspondent
Can-Am Surgical Corp.
3068 Stonewood St.
Simi Valley,  CA  93063
Correspondent Contact COVER
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/20/1987
Decision Date 04/16/1987
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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