The following data is part of a premarket notification filed by Progressive Woundcare Technologies, Llc with the FDA for Iodofoam Iodophor Foam Dressing.
Device ID | K122634 |
510k Number | K122634 |
Device Name: | IODOFOAM IODOPHOR FOAM DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC 150 LEVINBERG LANE Wayne, NJ 07470 |
Contact | Mason Diamond |
Correspondent | Mason Diamond PROGRESSIVE WOUNDCARE TECHNOLOGIES, LLC 150 LEVINBERG LANE Wayne, NJ 07470 |
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 | 2012-08-29 |
Decision Date | 2013-03-12 |
Summary: | summary |