SNAP (R) WOUND CARE SYSTEM


Device Classification Name

negative pressure wound therapy non-powered suction apparatus

510(k) Number K111393
Device Name SNAP (R) WOUND CARE SYSTEM
Applicant
SPIRACUR, INC.
755 n. mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Applicant Contact sarah canio
Correspondent
SPIRACUR, INC.
755 n. mathilda avenue
suite 100
sunnyvale, 
CA 
94085

Correspodent Contact sarah canio
Regulation Number 878.4680
Classification Product Code
OKO  
Date Received 05/18/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No