Submission Details
| 510(k) Number | K833664 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 1983 |
| Decision Date | December 27, 1983 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
ARMBOARD AND THE BOARD
Dec 1983
Decision
70d
Days
Class 1
Risk
About This 510(k) Submission
K833664 is an FDA 510(k) clearance for the ARMBOARD AND THE BOARD, a Board, Arm (with Cover), Sterile (Class I — General Controls, product code BTX), submitted by Rick Robbin & Frederick Auerbach (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983, 70 days after receiving the submission on October 18, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3910.
Device Classification
| Product Code | BTX — Board, Arm (with Cover), Sterile |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.3910 |
Manufacturer
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