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 |