510(k) K952787

FOAM INSTRUMENT GUARD by Oxboro Medical Intl., Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
June 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type