The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Alveolar Distractor.
| Device ID | K981526 |
| 510k Number | K981526 |
| Device Name: | ACE ALVEOLAR DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | Edward J Carchidi |
| Correspondent | Edward J Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-28 |
| Decision Date | 1998-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00614950030897 | K981526 | 000 |
| 00614950030880 | K981526 | 000 |
| 00614950030873 | K981526 | 000 |
| 00614950030866 | K981526 | 000 |