K020327 is an FDA 510(k) clearance for the SURGIC IV IMPLANT CONTROL UNIT. This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Nakanishi, Inc. (Kanuma-Shi, JP). The FDA issued a Cleared decision on April 8, 2002, 67 days after receiving the submission on January 31, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K020327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2002 |
| Decision Date | April 08, 2002 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBW — Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |