The following data is part of a premarket notification filed by Andersen Products, Inc. with the FDA for Andersen Intestinal Tube, Miller-abbott Type (an 22).
| Device ID | K011077 |
| 510k Number | K011077 |
| Device Name: | ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ANDERSEN PRODUCTS, INC. 3202 CAROLINE DR., HEALTH SCIENCE PARK Haw River, NC 27258 -8710 |
| Contact | Wendy Hedrick |
| Correspondent | Wendy Hedrick ANDERSEN PRODUCTS, INC. 3202 CAROLINE DR., HEALTH SCIENCE PARK Haw River, NC 27258 -8710 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-09 |
| Decision Date | 2001-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060171440581 | K011077 | 000 |
| 05060171440574 | K011077 | 000 |
| 05060171440567 | K011077 | 000 |
| 05060171440550 | K011077 | 000 |
| 05060171440543 | K011077 | 000 |
| 05060171440536 | K011077 | 000 |
| 05060171440352 | K011077 | 000 |
| 05060171440345 | K011077 | 000 |