510(k) K890387
K890387 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "MALLEABLE PLACENTA CURETTE". The FDA issued a decision of Substantially Equivalent on February 27, 1989. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Kinetic Medical Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1989
- Date Received
- January 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colposcope (And Colpomicroscope)
- Device Class
- Class II
- Regulation Number
- 884.1630
- Review Panel
- OB
- Submission Type