510(k) K921401

BIOPSY FORCEPS by Annex Medical, Inc. — Product Code DWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1992
Date Received
March 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biopsy, Endomyocardial
Device Class
Class II
Regulation Number
870.4075
Review Panel
CV
Submission Type