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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 K864414
Device Name SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC)
Applicant
Seal Syringe Corp.
1621 Collingwood Dr.
San Diego,  CA  92109
Applicant Contact JOSEPH SOUTHWORTH
Correspondent
Seal Syringe Corp.
1621 Collingwood Dr.
San Diego,  CA  92109
Correspondent Contact JOSEPH SOUTHWORTH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/07/1986
Decision Date 12/18/1986
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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