The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Supplemental Feeding System.
Device ID | K844297 |
510k Number | K844297 |
Device Name: | SUPPLEMENTAL FEEDING SYSTEM |
Classification | Pump, Breast, Non-powered |
Applicant | MEDELA, INC. 6711 SANDS RD. Crystal Lake, IL 60014 |
Contact | Gotthilf Weiniger |
Correspondent | Gotthilf Weiniger MEDELA, INC. 6711 SANDS RD. Crystal Lake, IL 60014 |
Product Code | HGY |
CFR Regulation Number | 884.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-29 |
Decision Date | 1985-02-25 |