The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Flex Sigmoidoscope Light Source Model #45150.
| Device ID | K893440 |
| 510k Number | K893440 |
| Device Name: | FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John Watkins |
| Correspondent | John Watkins WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-03 |
| Decision Date | 1989-07-28 |