The following data is part of a premarket notification filed by Tendasoft, Inc. with the FDA for Unscented Menstrual Pad.
Device ID | K953633 |
510k Number | K953633 |
Device Name: | UNSCENTED MENSTRUAL PAD |
Classification | Pad, Menstrual, Unscented |
Applicant | TENDASOFT, INC. 1001 VISION DR. Van Wert, OH 45891 |
Contact | Derek Dafoe |
Correspondent | Derek Dafoe TENDASOFT, INC. 1001 VISION DR. Van Wert, OH 45891 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-04 |
Decision Date | 1995-11-01 |