The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Flexible Nasopharyngoscope.
Device ID | K896297 |
510k Number | K896297 |
Device Name: | FLEXIBLE NASOPHARYNGOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
Contact | Craig Rapp |
Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-30 |
Decision Date | 1990-01-26 |