The following data is part of a premarket notification filed by Schoelly Imaging, Inc. with the FDA for Naso-laryngo-pharyngoscope.
| Device ID | K083553 |
| 510k Number | K083553 |
| Device Name: | NASO-LARYNGO-PHARYNGOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | SCHOELLY IMAGING, INC. 200 Homer Avenue Ashland, MA 01721 |
| Contact | F. David Rothkopf |
| Correspondent | F. David Rothkopf SCHOELLY IMAGING, INC. 200 Homer Avenue Ashland, MA 01721 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-01 |
| Decision Date | 2009-01-16 |
| Summary: | summary |