The following data is part of a premarket notification filed by Bissell Medical Products, Inc. with the FDA for Baker Twin-cuff Intestinal Decomp/plication Tube.
| Device ID | K873441 |
| 510k Number | K873441 |
| Device Name: | BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BISSELL MEDICAL PRODUCTS, INC. 135 SOUTH LASALLE ST. Chicago, IL 60603 |
| Contact | Sharyl A Dewane |
| Correspondent | Sharyl A Dewane BISSELL MEDICAL PRODUCTS, INC. 135 SOUTH LASALLE ST. Chicago, IL 60603 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-27 |
| Decision Date | 1987-10-27 |