510(k) K770476

EXAM GOWN by General Medical Co. — Product Code FME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1977
Date Received
March 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Examination
Device Class
Class I
Regulation Number
880.6265
Review Panel
HO
Submission Type