Device Classification Name |
Blade, Saw, General & Plastic Surgery, Surgical
|
510(k) Number |
K933595 |
Device Name |
BUR, SURGICAL, GENERAL & PLASTIC SURGERY |
Applicant |
OMEGA SURGICAL INSTRUMENTS, INC. |
11415 ORCHARDVIEW DR. |
FENTON,
MI
48430
|
|
Applicant Contact |
GARY L ADAM |
Correspondent |
OMEGA SURGICAL INSTRUMENTS, INC. |
11415 ORCHARDVIEW DR. |
FENTON,
MI
48430
|
|
Correspondent Contact |
GARY L ADAM |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 07/26/1993 |
Decision Date | 03/16/1994 |
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
|
|
|