The following data is part of a premarket notification filed by Natracare, Llc. with the FDA for Natracare Menstrual Pads.
Device ID | K940329 |
510k Number | K940329 |
Device Name: | NATRACARE MENSTRUAL PADS |
Classification | Pad, Menstrual, Unscented |
Applicant | NATRACARE, LLC. 191 UNIVERSITY BLVD., STE.294 Denver, CO 80206 |
Contact | Susan Carskadon |
Correspondent | Susan Carskadon NATRACARE, LLC. 191 UNIVERSITY BLVD., STE.294 Denver, CO 80206 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-24 |
Decision Date | 1994-04-13 |