The following data is part of a premarket notification filed by Effner, Inc. with the FDA for Effner Illuminated Nasal Tracheostoma Speculum.
| Device ID | K882744 |
| 510k Number | K882744 |
| Device Name: | EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | EFFNER, INC. POST OFFICE BOX 191 Port Washington, NY 11050 |
| Contact | Inge Hamer |
| Correspondent | Inge Hamer EFFNER, INC. POST OFFICE BOX 191 Port Washington, NY 11050 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-01 |
| Decision Date | 1988-08-10 |