POWERPRESS UNIT


Device Classification Name

sleeve, limb, compressible

510(k) Number K110276
Device Name POWERPRESS UNIT
Applicant
HANURI DISTRIBUTION, INC
9601 owensmouth avenue
# 8
chatsworth, 
CA 
91311

Applicant Contact jung hyun moon
Correspondent
HANURI DISTRIBUTION, INC
9601 owensmouth avenue
# 8
chatsworth, 
CA 
91311

Correspodent Contact jung hyun moon
Regulation Number 870.5800
Classification Product Code
JOW  
Subsequent Product Code
IRP  
Date Received 01/31/2011
Decision Date 11/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No