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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 K963364
Device Name GLASS VAN GLASS SYRINGES
Applicant
Myco Medical Supplies, Inc.
6640 Portsmouth Ln.
Raleigh,  NC  27615
Applicant Contact SANJIV KUMAR
Correspondent
Myco Medical Supplies, Inc.
6640 Portsmouth Ln.
Raleigh,  NC  27615
Correspondent Contact SANJIV KUMAR
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/26/1996
Decision Date 05/01/1998
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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