Submission Details
| 510(k) Number | K884838 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 1988 |
| Decision Date | December 15, 1988 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
ALLEN PRONE ARMBOARD
Dec 1988
Decision
24d
Days
Class 1
Risk
About This 510(k) Submission
K884838 is an FDA 510(k) clearance for the ALLEN PRONE ARMBOARD, a Board, Arm (with Cover), Sterile (Class I — General Controls, product code BTX), submitted by Edgewater Medical Systems, Inc. (Mayfield Hts., US). The FDA issued a Cleared decision on December 15, 1988, 24 days after receiving the submission on November 21, 1988. 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
Similar Devices — BTX Board, Arm (with Cover), Sterile
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