The following data is part of a premarket notification filed by Biolife, Llc with the FDA for Pro Qr (quick Relief) Powder (for Minor External Bleeding From Wounds & Procedures).
| Device ID | K070520 |
| 510k Number | K070520 |
| Device Name: | PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) |
| 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 | 2007-02-23 |
| Decision Date | 2007-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00834061003201 | K070520 | 000 |
| 00834061006318 | K070520 | 000 |
| 00834061000026 | K070520 | 000 |
| 00834061000040 | K070520 | 000 |
| 00834061000057 | K070520 | 000 |
| 00834061000064 | K070520 | 000 |
| 00834061000071 | K070520 | 000 |
| 00834061000101 | K070520 | 000 |
| 00834061000378 | K070520 | 000 |
| 00834061000392 | K070520 | 000 |
| 00834061000446 | K070520 | 000 |
| 00834061000453 | K070520 | 000 |
| 00834061000477 | K070520 | 000 |
| 00834061000491 | K070520 | 000 |
| 00834061003102 | K070520 | 000 |
| 00834061003195 | K070520 | 000 |
| 00834061002358 | K070520 | 000 |