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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 K992351
Device Name SEALOUETTE FIBRIN SEALANT APPLICATOR
Applicant
Biosurgical Corp.
5990 Stoneridge Ave.,
Suite 112
Pleasanton,  CA  94566
Applicant Contact TERRY E LAAS
Correspondent
Biosurgical Corp.
5990 Stoneridge Ave.,
Suite 112
Pleasanton,  CA  94566
Correspondent Contact TERRY E LAAS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/14/1999
Decision Date 10/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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