Submission Details
| 510(k) Number | K953071 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 30, 1995 |
| Decision Date | August 08, 1995 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
STRYKER COMMAND2 OFFICE CONSOLE
Aug 1995
Decision
39d
Days
Class 1
Risk
About This 510(k) Submission
K953071 is an FDA 510(k) clearance for the STRYKER COMMAND2 OFFICE CONSOLE, a Table, Surgical With Orthopedic Accessories, Ac-powered (Class I — General Controls, product code JEA), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 8, 1995, 39 days after receiving the submission on June 30, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.
Device Classification
| Product Code | JEA — Table, Surgical With Orthopedic Accessories, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4960 |
Manufacturer
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