The following data is part of a premarket notification filed by Reliance Products Corp. with the FDA for Nuk Breast Shield.
Device ID | K833450 |
510k Number | K833450 |
Device Name: | NUK BREAST SHIELD |
Classification | Shield, Nipple |
Applicant | RELIANCE PRODUCTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HFS |
CFR Regulation Number | 880.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-05 |
Decision Date | 1983-11-21 |