Device Classification Name |
Tourniquet, Pneumatic
|
510(k) Number |
K952038 |
Device Name |
CLEAN-CUFF |
Applicant |
INSTRUMED, INC. |
11818 N. CREEK PARKWAY NORTH |
SUITE 105 |
BOTHELL,
WA
98011
|
|
Applicant Contact |
JERRY L SPENCE |
Correspondent |
INSTRUMED, INC. |
11818 N. CREEK PARKWAY NORTH |
SUITE 105 |
BOTHELL,
WA
98011
|
|
Correspondent Contact |
JERRY L SPENCE |
Regulation Number | 878.5910
|
Classification Product Code |
|
Date Received | 05/01/1995 |
Decision Date | 07/11/1995 |
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
|
Recalls |
CDRH Recalls
|
|
|