The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Quick Lock Imf System.
Device ID | K991004 |
510k Number | K991004 |
Device Name: | SYNTHES QUICK LOCK IMF SYSTEM |
Classification | Lock, Wire, And Ligature, Intraoral |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | DYX |
CFR Regulation Number | 872.4600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-25 |
Decision Date | 1999-06-23 |
Summary: | summary |