510(k) K172414
K172414 is an FDA 510(k) premarket notification submitted by Global Mailer Partners, LLC for the device "JUD custom fit condom". The FDA issued a decision of Substantially Equivalent on Oct 12, 2017. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 12, 2017
- Date Received
- Aug 10, 2017
- Clearance Type
- Abbreviated
- 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)