510(k) K960955

JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING by Baxter Healthcare Corp — Product Code GBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1996
Date Received
March 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type