The following data is part of a premarket notification filed by Doctor's Research Group, Inc. with the FDA for Lockjaw 15 Minute Intermaxillary Fixation System,model Lj100-00.
Device ID | K990212 |
510k Number | K990212 |
Device Name: | LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 |
Classification | Lock, Wire, And Ligature, Intraoral |
Applicant | DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
Contact | Richard Deslauriers |
Correspondent | Richard Deslauriers DOCTOR'S RESEARCH GROUP, INC. 143 WOLCOTT RD. Wolcott, CT 06716 |
Product Code | DYX |
CFR Regulation Number | 872.4600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-22 |
Decision Date | 1999-09-14 |