Device Classification Name |
Dermatome
|
510(k) Number |
K861285 |
Device Name |
SKIN MESH DEVICE |
Applicant |
PRECISION MODIFIED DEVICES |
1239 EAST 3800 SOUTH |
SALT LAKE CITY,
UT
84106
|
|
Applicant Contact |
KATHY M SMITH |
Correspondent |
PRECISION MODIFIED DEVICES |
1239 EAST 3800 SOUTH |
SALT LAKE CITY,
UT
84106
|
|
Correspondent Contact |
KATHY M SMITH |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 04/07/1986 |
Decision Date | 04/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|