510(k) K945144

SPONGE COUNT by Michael Fischer Assoc. — Product Code LWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1995
Date Received
October 20, 1994
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