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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 K931095
Device Name SPRING LOADED SYRINGE
Applicant
Acacia, Inc.
P.O. Box 1799
Ojai,  CA  93023
Applicant Contact JAMES SULLIVAN
Correspondent
Acacia, Inc.
P.O. Box 1799
Ojai,  CA  93023
Correspondent Contact JAMES SULLIVAN
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/03/1993
Decision Date 09/16/1993
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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