The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Kangaroo Enteral Feeding Extension Set For Syringe Pumps.
Device ID | K973409 |
510k Number | K973409 |
Device Name: | KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
Contact | Vanada Johnson |
Correspondent | Vanada Johnson DAVIS & GECK, INC. 444 MC DONNELL BLVD. Hazelwood, MO 63042 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-09 |
Decision Date | 1998-02-27 |
Summary: | summary |