The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Spray Catheter Pw-6c-1.
| Device ID | K012073 |
| 510k Number | K012073 |
| Device Name: | OLYMPUS SPRAY CATHETER PW-6C-1 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170156236 | K012073 | 000 |