The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Nasostat.
Device ID | K800175 |
510k Number | K800175 |
Device Name: | NASOSTAT |
Classification | Balloon, Epistaxis |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EMX |
CFR Regulation Number | 874.4100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-28 |
Decision Date | 1980-02-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NASOSTAT 72457426 0988514 Dead/Expired |
GOTTSCHALK, GEORGE H. 1973-05-14 |