The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Mh-246r Balloon Sheath.
| Device ID | K961048 |
| 510k Number | K961048 |
| Device Name: | OLYMPUS MH-246R BALLOON SHEATH |
| Classification | Endoscopic Ultrasound System, Gastroenterology-urology |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | ODG |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-15 |
| Decision Date | 1996-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170365130 | K961048 | 000 |
| 14953170365123 | K961048 | 000 |
| 14953170365116 | K961048 | 000 |
| 14953170061872 | K961048 | 000 |
| 14953170059077 | K961048 | 000 |
| 14953170058995 | K961048 | 000 |
| 14953170463515 | K961048 | 000 |
| 14953170463508 | K961048 | 000 |