The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tambrands Inc. Ill.p. 2.
Device ID | K843061 |
510k Number | K843061 |
Device Name: | TAMBRANDS INC. ILL.P. 2 |
Classification | Pad, Menstrual, Unscented |
Applicant | TAMBRANDS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-03 |
Decision Date | 1984-08-24 |