FME — Gown, Examination Class I

FDA Device Classification

Classification Details

Product Code
FME
Device Class
Class I
Regulation Number
880.6265
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K880385kimberly-clarkKIMBERLY-CLARK PROFESSIONAL JACKETFebruary 19, 1988
K811915american hospital supplyMONITOR/VITAL SIGNS TRAYJuly 28, 1981
K770476general medicalEXAM GOWNMay 6, 1977
K760954graham manufacturingCROWNTEX EXAM. CAPE & GOWNDecember 30, 1976
K760360preceptSHIRT, MITTEN CUFF INFANTOctober 20, 1976