The following data is part of a premarket notification filed by Engineered Medical Solutions Co. Llc with the FDA for Scintillant Surgical Light, Model 2644-01-0001.
| Device ID | K071180 |
| 510k Number | K071180 |
| Device Name: | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 |
| Classification | Lamp, Surgical |
| Applicant | ENGINEERED MEDICAL SOLUTIONS CO. LLC 342E. MAIN STREET, SUITE 211 Leola, PA 17540 |
| Contact | William G Mclain |
| Correspondent | Patricia L Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-04-30 |
| Decision Date | 2007-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20865082000119 | K071180 | 000 |