Device Classification Name |
retractor
|
510(k) Number |
K853114 |
Device Name |
ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR |
Applicant |
AUSTRALIAN BIOMEDICAL CORPORATION LTD. |
39 DEHAVILLAND ROAD |
MORDIALLOC, VIC. 3195 |
AUSTRALIA,
AU
|
|
Applicant Contact |
J. D COOK |
Correspondent |
AUSTRALIAN BIOMEDICAL CORPORATION LTD. |
39 DEHAVILLAND ROAD |
MORDIALLOC, VIC. 3195 |
AUSTRALIA,
AU
|
|
Correspondent Contact |
J. D COOK |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 07/24/1985 |
Decision Date | 08/06/1985 |
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
|