The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Sigmoidoscope Tipless.
| Device ID | K790610 |
| 510k Number | K790610 |
| Device Name: | SIGMOIDOSCOPE TIPLESS |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | WELCH ALLYN, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FAM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-29 |
| Decision Date | 1979-04-23 |