The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Mh-246r Balloon Sheath, For Urinary Tract Use.
| Device ID | K982734 |
| 510k Number | K982734 |
| Device Name: | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-taylor |
| Correspondent | Laura Storms-taylor THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-05 |
| Decision Date | 1998-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170368547 | K982734 | 000 |
| 04953170061899 | K982734 | 000 |