The following data is part of a premarket notification filed by Lutech Industries, Inc. with the FDA for Lt-300 Hd.
| Device ID | K160380 |
| 510k Number | K160380 |
| Device Name: | LT-300 HD |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | Lutech Industries, Inc. 105 Remington Blvd., Suite C Ronkonkoma, NY 11779 |
| Contact | Ronald Vachula |
| Correspondent | Jimmy Wu LEE & XIAO 2600 MISSION ST, STE100 San Marino, CA 91108 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-10 |
| Decision Date | 2016-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B299LT300HD0 | K160380 | 000 |