The following data is part of a premarket notification filed by Radius Intl., Inc. with the FDA for Radius Enteral Feeding Tube.
Device ID | K930510 |
510k Number | K930510 |
Device Name: | RADIUS ENTERAL FEEDING TUBE |
Classification | Tube, Nasogastric |
Applicant | RADIUS INTL., INC. 21860 WEST WASHINGTON ST. Grayslake, IL 60030 |
Contact | David G Quinn |
Correspondent | David G Quinn RADIUS INTL., INC. 21860 WEST WASHINGTON ST. Grayslake, IL 60030 |
Product Code | BSS |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-01 |
Decision Date | 1995-02-01 |