Submission Details
| 510(k) Number | K881292 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 28, 1988 |
| Decision Date | April 07, 1988 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
ALLEN LATERAL ARMBOARD
Apr 1988
Decision
10d
Days
Class 1
Risk
About This 510(k) Submission
K881292 is an FDA 510(k) clearance for the ALLEN LATERAL 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 April 7, 1988, 10 days after receiving the submission on March 28, 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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