Device Classification Name |
Retractor
|
510(k) Number |
K830287 |
Device Name |
ZIMMER SKIN PROTECTOR |
Applicant |
ZIMMER, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ZIMMER, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 01/27/1983 |
Decision Date | 03/09/1983 |
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
|
|
|