Submission Details
| 510(k) Number | K943820 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 05, 1994 |
| Decision Date | November 02, 1994 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
STAT PAK
Nov 1994
Decision
89d
Days
Class 1
Risk
About This 510(k) Submission
K943820 is an FDA 510(k) clearance for the STAT PAK, a Burnisher, Operative (Class I — General Controls, product code EKJ), submitted by Magnum Instruments, Inc. (Glendale Hts., US). The FDA issued a Cleared decision on November 2, 1994, 89 days after receiving the submission on August 5, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.
Device Classification
| Product Code | EKJ — Burnisher, Operative |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |
Manufacturer
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