The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Nasal And Sinus Endoscopes.
| Device ID | K944072 |
| 510k Number | K944072 |
| Device Name: | OLYMPUS NASAL AND SINUS ENDOSCOPES |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-22 |
| Decision Date | 1995-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761070096 | K944072 | 000 |
| 04042761006095 | K944072 | 000 |
| 04042761006101 | K944072 | 000 |
| 04042761029216 | K944072 | 000 |
| 04042761053884 | K944072 | 000 |
| 04042761070027 | K944072 | 000 |
| 04042761070034 | K944072 | 000 |
| 04042761070041 | K944072 | 000 |
| 04042761070058 | K944072 | 000 |
| 04042761070065 | K944072 | 000 |
| 04042761070072 | K944072 | 000 |
| 04042761070089 | K944072 | 000 |
| 04042761006057 | K944072 | 000 |