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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 K000048
Device Name SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
Applicant
Biosurgical Corp.
5990 Stoneridge Ave.,
Suite 112
Pleasanton,  CA  94566
Applicant Contact TERRY LAAS
Correspondent
Biosurgical Corp.
5990 Stoneridge Ave.,
Suite 112
Pleasanton,  CA  94566
Correspondent Contact TERRY LAAS
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/07/2000
Decision Date 01/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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