MANUKATEX


Device Classification Name

dressing, wound, drug

510(k) Number K110042
Device Name MANUKATEX
Applicant
MANUKA MEDICAL LIMITED
29442 pointe royale
laguna niguel, 
CA 
92677

Applicant Contact james smith
Correspondent
MANUKA MEDICAL LIMITED
29442 pointe royale
laguna niguel, 
CA 
92677

Correspodent Contact james smith
Classification Product Code
FRO  
Date Received 01/06/2011
Decision Date 03/24/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes