The following data is part of a premarket notification filed by Lutech Industries, Inc. with the FDA for Lt-300 Sd Digital Video Colposcope.
| Device ID | K170446 |
| 510k Number | K170446 |
| Device Name: | LT-300 SD Digital Video Colposcope |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | Lutech Industries, Inc. 105 Remington Blvd Suite C Ronkonkoma, NY 11779 |
| Contact | Leanna Vachula |
| Correspondent | Jimmy Wu Lee & Xiao 2600 Mission St. Suite 100 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 | 2017-02-14 |
| Decision Date | 2017-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B299LT300SD0 | K170446 | 000 |