The following data is part of a premarket notification filed by Z-medica Corporation with the FDA for Quikclot Ex.
Device ID | K072474 |
510k Number | K072474 |
Device Name: | QUIKCLOT EX |
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 | 2007-09-04 |
Decision Date | 2007-10-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841495104756 | K072474 | 000 |
50841495105109 | K072474 | 000 |
50841495120102 | K072474 | 000 |
00841495102004 | K072474 | 000 |
50841495105383 | K072474 | 000 |
50841495105727 | K072474 | 000 |
00841495102103 | K072474 | 000 |
50841495102894 | K072474 | 000 |
00841495103452 | K072474 | 000 |
00841495103506 | K072474 | 000 |
00841495104732 | K072474 | 000 |
20841495150252 | K072474 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUIKCLOT EX 77267001 not registered Dead/Abandoned |
Z-Medica Corporation 2007-08-29 |