The following data is part of a premarket notification filed by Biolife, Llc with the FDA for Pro Qr Advanced Formula Powder.
| Device ID | K080210 |
| 510k Number | K080210 |
| Device Name: | PRO QR ADVANCED FORMULA POWDER |
| Classification | Dressing, Wound, Drug |
| Applicant | BIOLIFE, LLC 1235 TALLEVAST RD. Sarasota, FL 34243 -3271 |
| Contact | Karen O'toole |
| Correspondent | Karen O'toole BIOLIFE, LLC 1235 TALLEVAST RD. Sarasota, FL 34243 -3271 |
| 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 | 2008-01-28 |
| Decision Date | 2009-02-10 |
| Summary: | summary |