510(k) K900088

MASKS SURGICAL DENTAL by Kab Gloves Unltd. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1990
Date Received
January 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type