The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Normed Bidirectrional/multidirectional Jaw Distractor.
| Device ID | K952847 |
| 510k Number | K952847 |
| Device Name: | NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Contact | J. Edward Carchidi |
| Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-21 |
| Decision Date | 1996-02-06 |