The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Spyglass Direct Visulation Probe.
| Device ID | K050403 |
| 510k Number | K050403 |
| Device Name: | SPYGLASS DIRECT VISULATION PROBE |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PLACE Natick, MA 01760 -1537 |
| Contact | Kathleen Morahan |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-02-17 |
| Decision Date | 2005-03-04 |
| Summary: | summary |