The following data is part of a premarket notification filed by Innovative Therapies, Inc. with the FDA for Antlia Iii Wound Treatment System.
Device ID | K111333 |
510k Number | K111333 |
Device Name: | ANTLIA III WOUND TREATMENT SYSTEM |
Classification | Negative Pressure Wound Therapy Powered Suction Pump |
Applicant | INNOVATIVE THERAPIES, INC. 12 MEEM AVE, SUITE C Gaithersburg, MD 20877 |
Contact | Judith Harbour |
Correspondent | Judith Harbour INNOVATIVE THERAPIES, INC. 12 MEEM AVE, SUITE C Gaithersburg, MD 20877 |
Product Code | OMP |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-12 |
Decision Date | 2011-08-08 |
Summary: | summary |