The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Mandible Distractor.
Device ID | K962272 |
510k Number | K962272 |
Device Name: | SYNTHES MANDIBLE DISTRACTOR |
Classification | External Mandibular Fixator And/or Distractor |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Angela J Silvestri |
Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | MQN |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-13 |
Decision Date | 1996-08-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H9802879540 | K962272 | 000 |
H9802879530 | K962272 | 000 |