Submission Details
| 510(k) Number | K071180 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2007 |
| Decision Date | June 20, 2007 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
Jun 2007
Decision
51d
Days
Class 2
Risk
About This 510(k) Submission
K071180 is an FDA 510(k) clearance for the SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001, a Lamp, Surgical (Class II — Special Controls, product code FTD), submitted by Engineered Medical Solutions Co., LLC (Leola, US). The FDA issued a Cleared decision on June 20, 2007, 51 days after receiving the submission on April 30, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
Device Classification
| Product Code | FTD — Lamp, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |
Manufacturer
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