Device Classification Name |
tourniquet, pneumatic
|
510(k) Number |
K910449 |
Device Name |
PRESTITCH |
Applicant |
CRANTEC CO. |
120 SPORTS MALL PLAZA 5505 |
SOUTH 900 E. |
SALT LAKE CITY,
UT
84117
|
|
Applicant Contact |
RICHARD CRANGLE |
Correspondent |
CRANTEC CO. |
120 SPORTS MALL PLAZA 5505 |
SOUTH 900 E. |
SALT LAKE CITY,
UT
84117
|
|
Correspondent Contact |
RICHARD CRANGLE |
Regulation Number | 878.5910
|
Classification Product Code |
|
Date Received | 01/29/1991 |
Decision Date | 05/29/1992 |
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
|
|
|