The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Modified Maxithins Panty Shields Unscented.
Device ID | K862677 |
510k Number | K862677 |
Device Name: | MODIFIED MAXITHINS PANTY SHIELDS UNSCENTED |
Classification | Pad, Menstrual, Unscented |
Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Contact | Staab, Phd |
Correspondent | Staab, Phd TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-14 |
Decision Date | 1986-08-15 |