The following data is part of a premarket notification filed by Bilson International, Inc. with the FDA for Bilsom Propp.
Device ID | K791608 |
510k Number | K791608 |
Device Name: | BILSOM PROPP |
Classification | Protector, Hearing (insert) |
Applicant | BILSON INTERNATIONAL, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | EWD |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-13 |
Decision Date | 1979-10-10 |