The following data is part of a premarket notification filed by Schott Fiber Optics, Inc. with the FDA for Flexible Immersible Sigmoidoscope.
| Device ID | K892000 |
| 510k Number | K892000 |
| Device Name: | FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | SCHOTT FIBER OPTICS, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Contact | Richard F Taylor |
| Correspondent | Richard F Taylor SCHOTT FIBER OPTICS, INC. 122 CHARLTON ST. Southbridge, MA 01550 |
| Product Code | FAM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-04-25 |