510(k) K161106
K161106 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC DISPOSABLE VACUUM CURETTES". The FDA issued a decision of Substantially Equivalent on January 13, 2017. The device falls under product code HGH (Cannula, Suction, Uterine), a Class II device regulated under 21 CFR 884.5070. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2017
- Date Received
- April 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Suction, Uterine
- Device Class
- Class II
- Regulation Number
- 884.5070
- Review Panel
- OB
- Submission Type