The following data is part of a premarket notification filed by Johnson & Johnson Worldwide with the FDA for Unscented Menstrual Tampon.
Device ID | K941936 |
510k Number | K941936 |
Device Name: | UNSCENTED MENSTRUAL TAMPON |
Classification | Tampon, Menstrual, Unscented |
Applicant | JOHNSON & JOHNSON WORLDWIDE 1 VAN LIEW AVE., P.O. BOX 900 Milltown, NJ 08850 |
Contact | L. J Bremer |
Correspondent | L. J Bremer JOHNSON & JOHNSON WORLDWIDE 1 VAN LIEW AVE., P.O. BOX 900 Milltown, NJ 08850 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-20 |
Decision Date | 1994-07-29 |