| Device Classification Name |
Component, Traction, Invasive
|
| 510(k) Number |
K872538 |
| Device Name |
VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS |
| Applicant |
| Vitaphore Corp. |
| 887 Industrial Rd. |
|
San Carlos,
CA
94070
|
|
| Applicant Contact |
SOPHIA PESOTCHINSKY |
| Correspondent |
| Vitaphore Corp. |
| 887 Industrial Rd. |
|
San Carlos,
CA
94070
|
|
| Correspondent Contact |
SOPHIA PESOTCHINSKY |
| Regulation Number | 888.3040 |
| Classification Product Code |
|
| Date Received | 06/29/1987 |
| Decision Date | 07/10/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|