510(k) K013086
K013086 is an FDA 510(k) premarket notification submitted by Trigg Laboratories, Inc. for the device "WET LIGHT PERSONAL MOISTURIZER". The FDA issued a decision of Substantially Equivalent on Dec 13, 2001. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Trigg Laboratories, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2001
- Date Received
- Sep 14, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
- 510(k)