510(k) K915530

NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE by American Threshold Industries, Inc. — Product Code HAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1992
Date Received
December 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tong, Skull For Traction
Device Class
Class II
Regulation Number
882.5960
Review Panel
NE
Submission Type