510(k) K894228
K894228 is an FDA 510(k) premarket notification submitted by Kronner Medical for the device "KRONNER SPHERICAL CUTTERS". The FDA issued a decision of Substantially Equivalent on Jul 23, 1990. The device falls under product code HWT (Template), a Class I device regulated under 21 CFR 888.4800. Kronner Medical has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 23, 1990
- Date Received
- Jun 19, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Template
- Device Class
- Class I
- Regulation Number
- 888.4800
- Review Panel
- OR
- Submission Type