The following data is part of a premarket notification filed by Z-medica, Llc with the FDA for Quikclot Hemostatic Dressing.
| Device ID | K123387 |
| 510k Number | K123387 |
| Device Name: | QUIKCLOT HEMOSTATIC DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | Z-MEDICA, LLC 4 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Sheila Wallin |
| Correspondent | Sheila Wallin Z-MEDICA, LLC 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 | 2012-11-02 |
| Decision Date | 2013-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841495104879 | K123387 | 000 |
| 20841495150306 | K123387 | 000 |
| 20841495150290 | K123387 | 000 |
| 20841495150344 | K123387 | 000 |
| 30841495150358 | K123387 | 000 |
| 20841495150368 | K123387 | 000 |
| 30841495106362 | K123387 | 000 |
| 00841495104589 | K123387 | 000 |
| 50841495104591 | K123387 | 000 |
| 00841495104602 | K123387 | 000 |
| 00841495104619 | K123387 | 000 |
| 20841495150283 | K123387 | 000 |