Device Classification Name |
dressing, wound and burn, hydrogel w/drug and/or biologic
|
510(k) Number |
K970153 |
Device Name |
LAMIN-2 HYDRATING GEL |
Applicant |
PROCYTE CORP. |
12040 115TH AVE. N.E., #210 |
KIRKLAND,
WA
98034
|
|
Applicant Contact |
PAUL KETTERIDGE |
Correspondent |
PROCYTE CORP. |
12040 115TH AVE. N.E., #210 |
KIRKLAND,
WA
98034
|
|
Correspondent Contact |
PAUL KETTERIDGE |
Classification Product Code |
|
Date Received | 01/16/1997 |
Decision Date | 06/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|