The following data is part of a premarket notification filed by Focus Medical, Llc. with the FDA for Focus Medical 532 Hand Piece Adapter And Dye Pack Accessories (red Or Yellow).
| Device ID | K032667 |
| 510k Number | K032667 |
| Device Name: | FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FOCUS MEDICAL, LLC. 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Contact | John B Lee |
| Correspondent | John B Lee FOCUS MEDICAL, LLC. 23 FRANCIS J. CLARKE CIRCLE Bethel, CT 06801 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2004-01-23 |
| Summary: | summary |