Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K121227 |
Device Name |
MANUKA FILL |
Applicant |
LINKS MEDICAL PRODUCTS, INC. |
29442 POINTE ROYALE |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
James Smith |
Correspondent |
LINKS MEDICAL PRODUCTS, INC. |
29442 POINTE ROYALE |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
James Smith |
Classification Product Code |
|
Date Received | 04/23/2012 |
Decision Date | 05/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|