The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Balloon Dilator V (with Knife).
| Device ID | K150142 |
| 510k Number | K150142 |
| Device Name: | Single Use Balloon Dilator V (with Knife) |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi, JP 192-8507 |
| Contact | Toshiyuji Nakajima |
| Correspondent | Daphney Germain-kolawole OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-22 |
| Decision Date | 2015-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170373999 | K150142 | 000 |
| 14953170373975 | K150142 | 000 |
| 14953170373951 | K150142 | 000 |