The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Iodoform Packing Strips.
| Device ID | K052720 |
| 510k Number | K052720 |
| Device Name: | MEDLINE IODOFORM PACKING STRIPS |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| 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 | 2005-09-29 |
| Decision Date | 2005-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H65811258219 | K052720 | 000 |
| H65811258209 | K052720 | 000 |
| 20888277692326 | K052720 | 000 |