The following data is part of a premarket notification filed by Marks & Murase with the FDA for Nasopharyngoscope.
Device ID | K934422 |
510k Number | K934422 |
Device Name: | NASOPHARYNGOSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | MARKS & MURASE 399 PARK AVE. New York, NY 10022 -4689 |
Contact | Gary A Adler |
Correspondent | Gary A Adler MARKS & MURASE 399 PARK AVE. New York, NY 10022 -4689 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-13 |
Decision Date | 1994-01-27 |