The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Connect Internal Connection.
| Device ID | K041759 |
| 510k Number | K041759 |
| Device Name: | ACE CONNECT INTERNAL CONNECTION |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | J. Edwards Carchidi |
| Correspondent | J. Edwards 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 | 2004-06-29 |
| Decision Date | 2004-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950004041 | K041759 | 000 |
| 00614950004034 | K041759 | 000 |
| 00614950003990 | K041759 | 000 |
| 00614950003983 | K041759 | 000 |
| 00614950003976 | K041759 | 000 |
| 00614950003969 | K041759 | 000 |
| 00614950003952 | K041759 | 000 |
| 00614950003945 | K041759 | 000 |