The following data is part of a premarket notification filed by Midlothian Laboratories with the FDA for Tropazone Lotion.
Device ID | K090337 |
510k Number | K090337 |
Device Name: | TROPAZONE LOTION |
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 | 2009-02-10 |
Decision Date | 2009-08-13 |
Summary: | summary |