EMM SURGICAL GOWN – SPUNLACE WITH PE LAYER


Device Classification Name

gown, surgical

510(k) Number K111535
Device Name EMM SURGICAL GOWN – SPUNLACE WITH PE LAYER
Applicant
EXACT MEDICAL MANUFACTURING, INC
1083 delaware ave
buffalo, 
NY 
14209

Applicant Contact robert o dean
Correspondent
EXACT MEDICAL MANUFACTURING, INC
1083 delaware ave
buffalo, 
NY 
14209

Correspodent Contact robert o dean
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 06/02/2011
Decision Date 08/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No