The following data is part of a premarket notification filed by Salt Creek Medical Technologies with the FDA for Neonatal Feeding Kit.
Device ID | K864683 |
510k Number | K864683 |
Device Name: | NEONATAL FEEDING KIT |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | SALT CREEK MEDICAL TECHNOLOGIES 5500 ARAPAHO PASS Pinckney, MI 48169 |
Contact | Howard Meade |
Correspondent | Howard Meade SALT CREEK MEDICAL TECHNOLOGIES 5500 ARAPAHO PASS Pinckney, MI 48169 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-02 |
Decision Date | 1987-04-17 |