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510(k) K912839

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE by Baxter Healthcare Corp — Product Code FBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1991
Date Received
June 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filiform And Filiform Follower
Device Class
Class I
Regulation Number
876.5520
Review Panel
GU
Submission Type

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