Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K791137 |
Device Name |
SINGLE USE MONOPOLAR HAND CONTROL PENCIL |
Applicant |
DAVOL, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
DAVOL, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/18/1979 |
Decision Date | 07/24/1979 |
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
|
Recalls |
CDRH Recalls
|
|
|