510(k) K893874
K893874 is an FDA 510(k) premarket notification submitted by Altoona Medical Supply for the device "FUJITENS III". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code GZQ (Instrument, Dowel Cutting), a Class II device regulated under 21 CFR 882.4275. Altoona Medical Supply has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1989
- Date Received
- May 26, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Dowel Cutting
- Device Class
- Class II
- Regulation Number
- 882.4275
- Review Panel
- NE
- Submission Type