Device Classification Name |
tourniquet, nonpneumatic
|
510(k) Number |
K873928 |
Device Name |
UNIVERSAL TOURNIQUET |
Applicant |
DRYDEN CORP. |
10640 EAST 59TH ST. |
P.O. BOX 36038 |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
DRYDEN CORP. |
10640 EAST 59TH ST. |
P.O. BOX 36038 |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 878.5900
|
Classification Product Code |
|
Date Received | 09/25/1987 |
Decision Date | 10/23/1987 |
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
|
|
|