510(k) K190383
K190383 is an FDA 510(k) premarket notification submitted by Hamilton Thorne, Inc. for the device "GM501 Wash". The FDA issued a decision of Substantially Equivalent on September 5, 2019. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Hamilton Thorne, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2019
- Date Received
- February 19, 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