The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-ox, 09-2703-ox, 09-2705-ox.
| Device ID | K092594 |
| 510k Number | K092594 |
| Device Name: | ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | J.edward Carchidi |
| Correspondent | J.edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2009-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950003112 | K092594 | 000 |
| 00614950003082 | K092594 | 000 |
| 00614950003099 | K092594 | 000 |
| 00614950003105 | K092594 | 000 |
| 00614950003113 | K092594 | 000 |
| 00614950003129 | K092594 | 000 |
| 00614950003136 | K092594 | 000 |
| 00614950003143 | K092594 | 000 |
| 00614950003150 | K092594 | 000 |
| 00614950003075 | K092594 | 000 |
| 00614950003068 | K092594 | 000 |
| 00614950003051 | K092594 | 000 |
| 00614950002757 | K092594 | 000 |
| 00614950002764 | K092594 | 000 |
| 00614950002771 | K092594 | 000 |
| 00614950002788 | K092594 | 000 |
| 00614950002795 | K092594 | 000 |
| 00614950002801 | K092594 | 000 |
| 00614950002818 | K092594 | 000 |
| 00614950003044 | K092594 | 000 |
| 00614950003167 | K092594 | 000 |
| 00614950003174 | K092594 | 000 |
| 00614950003297 | K092594 | 000 |
| 00614950003303 | K092594 | 000 |
| 00614950003310 | K092594 | 000 |
| 00614950003327 | K092594 | 000 |
| 00614950003334 | K092594 | 000 |
| 00614950003341 | K092594 | 000 |
| 00614950003358 | K092594 | 000 |
| 00614950003365 | K092594 | 000 |
| 00614950003280 | K092594 | 000 |
| 00614950003273 | K092594 | 000 |
| 00614950003266 | K092594 | 000 |
| 00614950003181 | K092594 | 000 |
| 00614950003198 | K092594 | 000 |
| 00614950003204 | K092594 | 000 |
| 00614950003211 | K092594 | 000 |
| 00614950003228 | K092594 | 000 |
| 00614950003235 | K092594 | 000 |
| 00614950003242 | K092594 | 000 |
| 00614950003259 | K092594 | 000 |
| 00614950003372 | K092594 | 000 |