The following data is part of a premarket notification filed by Bissell Medical Products, Inc. with the FDA for Improved Baker Twin-cuff Sump Tube.
| Device ID | K901683 |
| 510k Number | K901683 |
| Device Name: | IMPROVED BAKER TWIN-CUFF SUMP TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BISSELL MEDICAL PRODUCTS, INC. 608 SOUTH WASHINGTON ST. # 201 Naperville, IL 60540 |
| Contact | Sharyl A Dewane |
| Correspondent | Sharyl A Dewane BISSELL MEDICAL PRODUCTS, INC. 608 SOUTH WASHINGTON ST. # 201 Naperville, IL 60540 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-10 |
| Decision Date | 1990-06-27 |