The following data is part of a premarket notification filed by Applied Osteo Systems, Inc. with the FDA for Pin Holders, Transfixing Pins, Ol Wires, Half Pins.
| Device ID | K932853 |
| 510k Number | K932853 |
| Device Name: | PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS |
| Classification | Curette, Biopsy, Bronchoscope (rigid) |
| Applicant | APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Contact | Scott Huntley |
| Correspondent | Scott Huntley APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Product Code | JEL |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-10 |
| Decision Date | 1994-02-22 |