The following data is part of a premarket notification filed by Reichert-jung, Inc. with the FDA for Reichert Flexible Laryngoscope, Model Ls-11.
Device ID | K852994 |
510k Number | K852994 |
Device Name: | REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 |
Classification | Laryngoscope, Non-rigid |
Applicant | REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
Contact | Richard F Taylor |
Correspondent | Richard F Taylor REICHERT-JUNG, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
Product Code | CAL |
CFR Regulation Number | 868.5530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-15 |
Decision Date | 1985-07-29 |