510(k) K930681

3M PREVENTION FABRIC SURGICAL GOWN #78XX by 3M Health Care, Ltd. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1994
Date Received
February 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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