Submission Details
| 510(k) Number | K915634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 17, 1991 |
| Decision Date | July 01, 1993 |
| Days to Decision | 562 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
Cleared
Traditional
FRESENIUS PD+ EXCHANGE DEVICE
Jul 1993
Decision
562d
Days
Class 1
Risk
About This 510(k) Submission
K915634 is an FDA 510(k) clearance for the FRESENIUS PD+ EXCHANGE DEVICE, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on July 1, 1993, 562 days after receiving the submission on December 17, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.
Device Classification
| Product Code | EKX — Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4200 |
Manufacturer
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