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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 K926007
Device Name ACCESSORY TO PISTON SYRINGE
Applicant
Martech Medical Products, Inc.
43223 Business Park Dr.
Temecula,  CA  92590
Applicant Contact STEVEN F MERCEREAU
Correspondent
Martech Medical Products, Inc.
43223 Business Park Dr.
Temecula,  CA  92590
Correspondent Contact STEVEN F MERCEREAU
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/27/1992
Decision Date 02/23/1993
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
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