The following data is part of a premarket notification filed by Radius Intl., Inc. with the FDA for Radius Low Profile Gastrostomy Tube Kit.
| Device ID | K971901 |
| 510k Number | K971901 |
| Device Name: | RADIUS LOW PROFILE GASTROSTOMY TUBE KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | RADIUS INTL., INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Ed Ransom |
| Correspondent | Ed Ransom RADIUS INTL., INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1998-01-22 |
| Summary: | summary |