510(k) K203727
K203727 is an FDA 510(k) premarket notification submitted by Pamco Distributing, Inc. for the device "Harmony Latex Dam, Harmony Non-Latex Dam". The FDA issued a decision of Substantially Equivalent on August 5, 2021. 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
- August 5, 2021
- Date Received
- December 21, 2020
- 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