510(k) K212928
K212928 is an FDA 510(k) premarket notification submitted by Brazen Goods Inc. Dba Lorals for the device "Lorals". The FDA issued a decision of Substantially Equivalent on Apr 22, 2022. The device falls under product code MSC (Barrier, Std, Oral Sex), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 22, 2022
- Date Received
- Sep 14, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Barrier, Std, Oral Sex
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type