The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for New Mother's Way-breast Pump.
Device ID | K834399 |
510k Number | K834399 |
Device Name: | NEW MOTHER'S WAY-BREAST PUMP |
Classification | Pump, Breast, Non-powered |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HGY |
CFR Regulation Number | 884.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-14 |
Decision Date | 1984-01-17 |