The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Tactylon(tm) Condom.
Device ID | K911431 |
510k Number | K911431 |
Device Name: | TACTYLON(TM) CONDOM |
Classification | Condom |
Applicant | TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
Contact | Buddenhagen |
Correspondent | Buddenhagen TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-02 |
Decision Date | 1994-12-27 |