The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Model #53110 Disposable Anoscope.
| Device ID | K810227 |
| 510k Number | K810227 |
| Device Name: | MODEL #53110 DISPOSABLE ANOSCOPE |
| Classification | Anoscope And Accessories |
| Applicant | WELCH ALLYN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-27 |
| Decision Date | 1981-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094074482 | K810227 | 000 |
| 00732094009750 | K810227 | 000 |
| 00732094009743 | K810227 | 000 |
| 00732094009736 | K810227 | 000 |
| 00732094007640 | K810227 | 000 |
| 00732094007633 | K810227 | 000 |
| 00732094007602 | K810227 | 000 |
| 00732094007541 | K810227 | 000 |
| 00732094009828 | K810227 | 000 |
| 00732094007664 | K810227 | 000 |
| 00732094007626 | K810227 | 000 |
| 00732094009767 | K810227 | 000 |
| 00732094009774 | K810227 | 000 |
| 00732094009804 | K810227 | 000 |
| 00732094074475 | K810227 | 000 |
| 00732094055696 | K810227 | 000 |
| 00732094009798 | K810227 | 000 |
| 00732094009781 | K810227 | 000 |
| 00732094007619 | K810227 | 000 |
| 00732094007596 | K810227 | 000 |
| 00732094007558 | K810227 | 000 |
| 00732094128222 | K810227 | 000 |
| 00732094128178 | K810227 | 000 |
| 00732094009811 | K810227 | 000 |
| 00732094007657 | K810227 | 000 |