The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Excelarrest Foam.
Device ID | K072900 |
510k Number | K072900 |
Device Name: | EXCELARREST FOAM |
Classification | Dressing, Wound, Drug |
Applicant | HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul, MN 55110 |
Contact | Keith Roberts |
Correspondent | Keith Roberts HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul, MN 55110 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-11 |
Decision Date | 2007-10-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858439001705 | K072900 | 000 |