The following data is part of a premarket notification filed by Kendall Mcgaw Laboratories, Inc. with the FDA for Mcgaw Nutra-feed Efs Enteral Feeding Tube.
Device ID | K862091 |
510k Number | K862091 |
Device Name: | MCGAW NUTRA-FEED EFS ENTERAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
Contact | Joyce Williams |
Correspondent | Joyce Williams KENDALL MCGAW LABORATORIES, INC. P.O. BOX 25080 Santa Ana, CA 92799 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-02 |
Decision Date | 1986-08-14 |