Device Classification Name |
blade, saw, general & plastic surgery, surgical
|
510(k) Number |
K933298 |
Device Name |
SAW BLADE |
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 | 07/07/1993 |
Decision Date | 08/09/1993 |
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
|
|
|