The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for A4722 Olympus Optical Obturator.
| Device ID | K950055 |
| 510k Number | K950055 |
| Device Name: | A4722 OLYMPUS OPTICAL OBTURATOR |
| Classification | Hysteroscope (and Accessories) |
| 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 | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-06 |
| Decision Date | 1995-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761006682 | K950055 | 000 |
| 04042761006521 | K950055 | 000 |