The following data is part of a premarket notification filed by Radius Intl., Inc. with the FDA for Radius Pull Percutaneous Endoscopic Gastrostomy Kit.
| Device ID | K972025 |
| 510k Number | K972025 |
| Device Name: | RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY 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 | 1997-06-02 |
| Decision Date | 1998-01-23 |
| Summary: | summary |