The following data is part of a premarket notification filed by J. Jamner Surgical Instruments, Inc. with the FDA for Jarit Recommended Sinus Instruments.
| Device ID | K944670 |
| 510k Number | K944670 |
| Device Name: | JARIT RECOMMENDED SINUS INSTRUMENTS |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | J. JAMNER SURGICAL INSTRUMENTS, INC. 9 SKYLINE DR. Hawthorne, NY 10532 |
| Contact | Patrice Edowney |
| Correspondent | Patrice Edowney J. JAMNER SURGICAL INSTRUMENTS, INC. 9 SKYLINE DR. Hawthorne, NY 10532 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-22 |
| Decision Date | 1995-02-02 |