510(k) K982260

MARKWELL GAUZE SPONGE by Markwell Intl., Inc. — Product Code LWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1998
Date Received
June 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Sponge, Surgical
Device Class
Class I
Regulation Number
880.2740
Review Panel
SU
Submission Type