The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Sigmoidoscope, Disposable, Model #53125.
| Device ID | K770291 |
| 510k Number | K770291 |
| Device Name: | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 |
| 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 | 1977-02-14 |
| Decision Date | 1977-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094144024 | K770291 | 000 |
| 00732094080957 | K770291 | 000 |
| 00732094080964 | K770291 | 000 |
| 00732094139051 | K770291 | 000 |
| 00732094139075 | K770291 | 000 |
| 00732094080384 | K770291 | 000 |
| 00732094080391 | K770291 | 000 |
| 00732094200300 | K770291 | 000 |
| 00732094079678 | K770291 | 000 |
| 00732094080612 | K770291 | 000 |
| 00732094080933 | K770291 | 000 |
| 00732094106046 | K770291 | 000 |
| 00732094106060 | K770291 | 000 |
| 00732094144000 | K770291 | 000 |
| 00732094080940 | K770291 | 000 |