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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K945454
Device Name LEUR TIP CAP, VLT CAP(TM)
Applicant
Martell Medical Products, Inc.
26637 Pierce Cir.
Murrieta,  CA  92562
Applicant Contact MICHAEL D MARTELL
Correspondent
Martell Medical Products, Inc.
26637 Pierce Cir.
Murrieta,  CA  92562
Correspondent Contact MICHAEL D MARTELL
Regulation Number862.1675
Classification Product Code
JKA  
Date Received11/07/1994
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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