The following data is part of a premarket notification filed by Trigg Laboratories, Inc. with the FDA for Wet Light Personal Moisturizer.
Device ID | K013086 |
510k Number | K013086 |
Device Name: | WET LIGHT PERSONAL MOISTURIZER |
Classification | Condom |
Applicant | TRIGG LABORATORIES, INC. WARNER CENTER PLAZA 21800 OXNARD STREET, SUITE 840 Woodland Hills, CA 91367 |
Contact | W. Patrick Noonan |
Correspondent | W. Patrick Noonan TRIGG LABORATORIES, INC. WARNER CENTER PLAZA 21800 OXNARD STREET, SUITE 840 Woodland Hills, CA 91367 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-14 |
Decision Date | 2001-12-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00716222251006 | K013086 | 000 |
00050428773192 | K013086 | 000 |
00050428523940 | K013086 | 000 |
00050428496893 | K013086 | 000 |
00716222203722 | K013086 | 000 |
00716222203715 | K013086 | 000 |
00716222203661 | K013086 | 000 |