The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Surgical Secure-mini Implant System, Model 09-270x-xx.
| Device ID | K073343 |
| 510k Number | K073343 |
| Device Name: | ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-28 |
| Decision Date | 2008-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950003419 | K073343 | 000 |
| 00614950002832 | K073343 | 000 |
| 00614950002849 | K073343 | 000 |
| 00614950002856 | K073343 | 000 |
| 00614950002863 | K073343 | 000 |
| 00614950002870 | K073343 | 000 |
| 00614950002887 | K073343 | 000 |
| 00614950002894 | K073343 | 000 |
| 00614950002900 | K073343 | 000 |
| 00614950002917 | K073343 | 000 |
| 00614950003389 | K073343 | 000 |
| 00614950003396 | K073343 | 000 |
| 00614950003402 | K073343 | 000 |
| 00614950002825 | K073343 | 000 |