The following data is part of a premarket notification filed by Superior Plastic Products Corp. with the FDA for 9 French 42long Polyurethane Graduated Enteric Fe.
| Device ID | K843975 |
| 510k Number | K843975 |
| Device Name: | 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SUPERIOR PLASTIC PRODUCTS CORP. COLUMBIA INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Paul Bernard |
| Correspondent | Paul Bernard SUPERIOR PLASTIC PRODUCTS CORP. COLUMBIA INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-11-20 |