Submission Details
| 510(k) Number | K893874 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 26, 1989 |
| Decision Date | December 22, 1989 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
Cleared
Traditional
K893874 - FUJITENS III
(FDA 510(k) Clearance)
Dec 1989
Decision
210d
Days
Class 2
Risk
K893874 is an FDA 510(k) clearance for the FUJITENS III, a Instrument, Dowel Cutting (Class II — Special Controls, product code GZQ), submitted by Altoona Medical Supply (Altoona, US). The FDA issued a Cleared decision on December 22, 1989, 210 days after receiving the submission on May 26, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4275.
Device Classification
| Product Code | GZQ — Instrument, Dowel Cutting |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4275 |