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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 K883957
Device Name ARTERIAL ANCHOR BANDAGE
Applicant
GUIDELINES, INC.
18441 NW 2ND AVE.
MIAMI,  FL  33169
Applicant Contact COHEN, PHD
Correspondent
GUIDELINES, INC.
18441 NW 2ND AVE.
MIAMI,  FL  33169
Correspondent Contact COHEN, PHD
Regulation Number878.4850
Classification Product Code
FMK  
Date Received09/19/1988
Decision Date 10/18/1988
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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