The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Modified Deodorant Maxithins Panty Shields.
Device ID | K862675 |
510k Number | K862675 |
Device Name: | MODIFIED DEODORANT MAXITHINS PANTY SHIELDS |
Classification | Pad, Menstrual, Scented |
Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Contact | Staab, Ph.d. |
Correspondent | Staab, Ph.d. TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Product Code | HHL |
CFR Regulation Number | 884.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-14 |
Decision Date | 1986-08-18 |