The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Mh-246r Balloon Sheath, For Female Reproductive Tract Use.
| Device ID | K982725 |
| 510k Number | K982725 |
| Device Name: | OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-taylor |
| Correspondent | Laura Storms-taylor OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-05 |
| Decision Date | 1998-10-23 |
| Summary: | summary |