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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 K945225
Device Name DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES
Applicant
MYCO MEDICAL SUPPLIES, INC.
6640 PORTSMOUTH LN.
RALEIGH,  NC  27615
Applicant Contact SANJIV K KUMAR
Correspondent
MYCO MEDICAL SUPPLIES, INC.
6640 PORTSMOUTH LN.
RALEIGH,  NC  27615
Correspondent Contact SANJIV K KUMAR
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received10/26/1994
Decision Date 01/26/1995
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
Recalls CDRH Recalls
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