The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Enteral Feeding Set, Model 20640.
Device ID | K061432 |
510k Number | K061432 |
Device Name: | HOSPIRA ENTERAL FEEDING SET, MODEL 20640 |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
Contact | Diane Rennpferd |
Correspondent | Diane Rennpferd HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-24 |
Decision Date | 2006-09-11 |
Summary: | summary |