The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Flow Thru 16,18,20,22 Fr Replace. Gastro Tube Kit.
| Device ID | K885339 |
| 510k Number | K885339 |
| Device Name: | FLOW THRU 16,18,20,22 FR REPLACE. GASTRO 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 | 1988-12-28 |
| Decision Date | 1989-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20043900950772 | K885339 | 000 |
| 20043900950741 | K885339 | 000 |
| 20043900950710 | K885339 | 000 |
| 20043900950680 | K885339 | 000 |
| 20043900950659 | K885339 | 000 |
| 20043900950628 | K885339 | 000 |