510(k) K951911

GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE) by Commercial Resources New Mexico, Ltd. — Product Code GDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
April 24, 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