Device Classification Name |
syringe, piston |
||||
---|---|---|---|---|---|
510(k) Number | K992351 | ||||
Device Name | SEALOUETTE FIBRIN SEALANT APPLICATOR | ||||
Applicant |
|
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Applicant Contact | terry e laas | ||||
Correspondent |
|
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Correspodent Contact | terry e laas | ||||
Regulation Number | 880.5860 | ||||
Classification Product Code |
|
||||
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 |