The following data is part of a premarket notification filed by Midlothian Laboratories with the FDA for Tropazone Cr.
| Device ID | K093544 |
| 510k Number | K093544 |
| Device Name: | TROPAZONE CR |
| Classification | Dressing, Wound, Drug |
| Applicant | MIDLOTHIAN LABORATORIES 760 INDUSTRIAL PARK BLVD. UNIT C Montgomery, AL 36117 |
| Contact | Bryce Harvey |
| Correspondent | Bryce Harvey MIDLOTHIAN LABORATORIES 760 INDUSTRIAL PARK BLVD. UNIT C Montgomery, AL 36117 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-11-17 |
| Decision Date | 2010-02-16 |
| Summary: | summary |