The following data is part of a premarket notification filed by Dr. Len's Medical Products Llc with the FDA for Abram's Multi-density Polyurethane Foam Wound Dressing System.
| Device ID | K033164 |
| 510k Number | K033164 |
| Device Name: | ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM |
| Classification | Dressing, Wound, Drug |
| Applicant | DR. LEN'S MEDICAL PRODUCTS LLC 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour DR. LEN'S MEDICAL PRODUCTS LLC 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| 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 | 2003-09-30 |
| Decision Date | 2004-09-07 |
| Summary: | summary |