510(k) K955599

STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE by Stryker Corp. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1996
Date Received
December 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal, X-Ray Detectable
Device Class
Class I
Regulation Number
878.4450
Review Panel
SU
Submission Type