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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K971487
Device Name BKMI DISPOSABLE SYRINGE
Applicant
SUMI SALUD C.A.
P.O. BOX 296
FRONT ROYAL,  VA  22630
Applicant Contact SUZANNE PARISIAN
Correspondent
SUMI SALUD C.A.
P.O. BOX 296
FRONT ROYAL,  VA  22630
Correspondent Contact SUZANNE PARISIAN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/23/1997
Decision Date 09/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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