BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE


Device Classification Name

surgeon’s gloves

510(k) Number K112257
Device Name BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
Applicant
MOLNLYCKE HEALTH CARE US, LLC
5550 peachtree parkway
suite 500
norcross, 
GA 
30092

Applicant Contact angela l bunn
Correspondent
MOLNLYCKE HEALTH CARE US, LLC
5550 peachtree parkway
suite 500
norcross, 
GA 
30092

Correspodent Contact angela l bunn
Regulation Number 878.4460
Classification Product Code
KGO  
Date Received 08/05/2011
Decision Date 09/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No