The following data is part of a premarket notification filed by Engineered Medical Solutions Co. Llc. with the FDA for Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical Light.
| Device ID | K133425 |
| 510k Number | K133425 |
| Device Name: | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT |
| Classification | Lamp, Surgical |
| Applicant | ENGINEERED MEDICAL SOLUTIONS CO. LLC. 85 INDUSTRIAL DR. BUILDING B Phillipsburg, NJ 08865 |
| Contact | Ryan Savage |
| Correspondent | Ryan Savage ENGINEERED MEDICAL SOLUTIONS CO. LLC. 85 INDUSTRIAL DR. BUILDING B Phillipsburg, NJ 08865 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-08 |
| Decision Date | 2013-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10865082000150 | K133425 | 000 |
| 10865082000143 | K133425 | 000 |