The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus B5-2c/b7-2c Balloon Catheter.
| Device ID | K962901 |
| 510k Number | K962901 |
| Device Name: | OLYMPUS B5-2C/B7-2C BALLOON CATHETER |
| Classification | Bronchoscope (flexible Or Rigid) |
| 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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-25 |
| Decision Date | 1996-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170047463 | K962901 | 000 |
| 14953170047395 | K962901 | 000 |