510(k) K192644
K192644 is an FDA 510(k) premarket notification submitted by Hamilton Thorne Incorporated for the device "GM501 SpermAir and GM501 SpermActive". The FDA issued a decision of Substantially Equivalent on Apr 23, 2020. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Hamilton Thorne Incorporated has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 2020
- Date Received
- Sep 24, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type
- 510(k)