Device Classification Name |
Blade, Saw, General & Plastic Surgery, Surgical
|
510(k) Number |
K950403 |
Device Name |
SURGICAL SAW BLADES |
Applicant |
TRANSIDYNE GENERAL CORP. |
400 HERALD JOURNAL PARK |
SPARTANBURG,
SC
29303
|
|
Applicant Contact |
STEVEN W BUTLER |
Correspondent |
TRANSIDYNE GENERAL CORP. |
400 HERALD JOURNAL PARK |
SPARTANBURG,
SC
29303
|
|
Correspondent Contact |
STEVEN W BUTLER |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 01/31/1995 |
Decision Date | 02/21/1995 |
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
|
|
|