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 |