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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single use only blood lancet with an integral sharps injury prevention feature
510(k) Number K870017
Device Name AMG + MED LANCET
Applicant
CAN-AM SURGICAL CORP.
3068 STONEWOOD ST.
SIMI VALLEY,  CA  93063
Applicant Contact ALLAN GOLDENBERG
Correspondent
CAN-AM SURGICAL CORP.
3068 STONEWOOD ST.
SIMI VALLEY,  CA  93063
Correspondent Contact ALLAN GOLDENBERG
Regulation Number878.4850
Classification Product Code
FMK  
Date Received01/02/1987
Decision Date 01/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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