The following data is part of a premarket notification filed by Andersen Products, Inc. with the FDA for Andersen Nasogastric Tube With Stylet, Models An 11s, 13s, 14s & 18s.
| Device ID | K021493 |
| 510k Number | K021493 |
| Device Name: | ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S |
| 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 | 2002-05-09 |
| Decision Date | 2002-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060171440710 | K021493 | 000 |
| 05060171440338 | K021493 | 000 |
| 05060171440444 | K021493 | 000 |
| 05060171440451 | K021493 | 000 |
| 05060171440468 | K021493 | 000 |
| 05060171440475 | K021493 | 000 |
| 05060171440482 | K021493 | 000 |
| 05060171440499 | K021493 | 000 |
| 05060171440505 | K021493 | 000 |
| 05060171440512 | K021493 | 000 |
| 05060171440529 | K021493 | 000 |
| 05060171440680 | K021493 | 000 |
| 05060171440697 | K021493 | 000 |
| 05060171440703 | K021493 | 000 |
| 05060171440321 | K021493 | 000 |