The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for 88000 Gastrostomy-jejunal Feeding Tube Kit.
| Device ID | K853353 |
| 510k Number | K853353 |
| Device Name: | 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Paul Bernard |
| Correspondent | Paul Bernard SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND 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 | 1985-08-12 |
| Decision Date | 1985-11-04 |