The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Enteral Feeding Tube.
Device ID | K963779 |
510k Number | K963779 |
Device Name: | RUSCH ENTERAL FEEDING TUBE |
Classification | Tube, Feeding |
Applicant | RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
Contact | Ronald J Young |
Correspondent | Ronald J Young RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
Product Code | FPD |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-20 |
Decision Date | 1997-05-23 |
Summary: | summary |