The following data is part of a premarket notification filed by Medi-tech Intl. Corp. with the FDA for Diamond Aloe Vera, Sterile.
Device ID | K002666 |
510k Number | K002666 |
Device Name: | DIAMOND ALOE VERA, STERILE |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | MEDI-TECH INTL. CORP. 26 COURT ST. Brooklyn, NY 11242 |
Contact | Herbert A Perry |
Correspondent | Herbert A Perry MEDI-TECH INTL. CORP. 26 COURT ST. Brooklyn, NY 11242 |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-25 |
Decision Date | 2001-02-27 |