The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Vitapatch Pin Protection Device For Percut. Pins.
| Device ID | K872538 |
| 510k Number | K872538 |
| Device Name: | VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS |
| Classification | Component, Traction, Invasive |
| Applicant | VITAPHORE CORP. 887 INDUSTRIAL RD. San Carlos, CA 94070 |
| Contact | Sophia Pesotchinsky |
| Correspondent | Sophia Pesotchinsky VITAPHORE CORP. 887 INDUSTRIAL RD. San Carlos, CA 94070 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-29 |
| Decision Date | 1987-07-10 |