The following data is part of a premarket notification filed by Val Med Corp. with the FDA for Val Lux 600 Surgical Light (plus And Rs), Model Ml600/s: Single Light Head, Ml600/ss: Single Light Head, Ml600/1d): Doub.
| Device ID | K010716 |
| 510k Number | K010716 |
| Device Name: | VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | VAL MED CORP. 555 THIRTEENTH ST. N.W. COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein VAL MED CORP. 555 THIRTEENTH ST. N.W. COLUMBIA SQUARE Washington, DC 20004 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-09 |
| Decision Date | 2001-05-30 |