The following data is part of a premarket notification filed by Darco Intl., Inc. with the FDA for Podospray Drill System.
| Device ID | K951773 |
| 510k Number | K951773 |
| Device Name: | PODOSPRAY DRILL SYSTEM |
| Classification | Motor, Surgical Instrument, Ac-powered |
| Applicant | DARCO INTL., INC. 815 CONNECTICUT AVENUE NW SUITE 1100 Washington, DC 20006 -4078 |
| Contact | Kevin M O'brien |
| Correspondent | Kevin M O'brien DARCO INTL., INC. 815 CONNECTICUT AVENUE NW SUITE 1100 Washington, DC 20006 -4078 |
| Product Code | GEY |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-17 |
| Decision Date | 1995-10-26 |