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 |