The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Quikclot Nosebleed.
Device ID | K080247 |
510k Number | K080247 |
Device Name: | QUIKCLOT NOSEBLEED |
Classification | Dressing, Wound, Drug |
Applicant | Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
Contact | Ronald E Peterson |
Correspondent | Ronald E Peterson Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
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 | 2008-01-31 |
Decision Date | 2008-02-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUIKCLOT NOSEBLEED 77570786 3745266 Dead/Cancelled |
Z-MEDICA, LLC 2008-09-16 |