The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Flexible Fiber-optic Nasopharyngoscope.
Device ID | K895245 |
510k Number | K895245 |
Device Name: | FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
Contact | Ehmsen, Scd |
Correspondent | Ehmsen, Scd OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-21 |
Decision Date | 1989-11-17 |