The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Spyglass Direct Visualization Probe And Ocular.
| Device ID | K052194 |
| 510k Number | K052194 |
| Device Name: | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Allyson Barford |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-08-24 |
| Summary: | summary |