NEODYNE DRESSING


Device Classification Name

elastomer, silicone, for scar management

510(k) Number K112131
Device Name NEODYNE DRESSING
Applicant
NEODYNE BIOSCIENCES, INC.
127 independence drive
menlo park, 
CA 
94025

Applicant Contact peggy mclaughlin
Correspondent
NEODYNE BIOSCIENCES, INC.
127 independence drive
menlo park, 
CA 
94025

Correspodent Contact peggy mclaughlin
Regulation Number 878.4025
Classification Product Code
MDA  
Date Received 07/26/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No