510(k) K935820
K935820 is an FDA 510(k) premarket notification submitted by Kolster Methods for the device "KOLSTER METHODS". The FDA issued a decision of Substantially Equivalent on July 19, 1994. The device falls under product code HGH (Cannula, Suction, Uterine), a Class II device regulated under 21 CFR 884.5070. Kolster Methods has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1994
- Date Received
- December 3, 1993
- 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