| Device Classification Name |
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
|
| 510(k) Number |
K933337 |
| Device Name |
R AND D BATTERY REPLACEMENT |
| Applicant |
| R & D Batteries, Inc. |
| 2224 E. 117th St. |
| P.O. Box 5007 |
|
Burnsville,
MN
55337
|
|
| Applicant Contact |
RANDALL C NODDINGS |
| Correspondent |
| R & D Batteries, Inc. |
| 2224 E. 117th St. |
| P.O. Box 5007 |
|
Burnsville,
MN
55337
|
|
| Correspondent Contact |
RANDALL C NODDINGS |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 07/08/1993 |
| Decision Date | 04/05/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|