SEALOUETTE FIBRIN SEALANT APPLICATOR


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

Correspodent Contact terry e laas
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 07/14/1999
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