Device Classification Name |
bur, surgical, general & plastic surgery
|
510(k) Number |
K943758 |
Device Name |
SURGICAL BUR |
Applicant |
KOMET MEDICAL |
800 KING GEORGE BLVD. |
SAVANNAH,
GA
31419
|
|
Applicant Contact |
COURTNEY S PARADICE |
Correspondent |
KOMET MEDICAL |
800 KING GEORGE BLVD. |
SAVANNAH,
GA
31419
|
|
Correspondent Contact |
COURTNEY S PARADICE |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 08/02/1994 |
Decision Date | 08/22/1994 |
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
|