The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Puracol Plus Ag Collagen Microscaffold Wound Dressing.
| Device ID | K071552 |
| 510k Number | K071552 |
| Device Name: | PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-06-06 |
| Decision Date | 2008-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888277720750 | K071552 | 000 |
| 30888277720743 | K071552 | 000 |
| 40884389155449 | K071552 | 000 |
| 40884389122953 | K071552 | 000 |
| 30193489081064 | K071552 | 000 |
| 20193489081050 | K071552 | 000 |
| 30080196316810 | K071552 | 000 |
| 40080196316800 | K071552 | 000 |