The following data is part of a premarket notification filed by John O. Butler with the FDA for Protect Drops/same As K874070.
Device ID | K874194 |
510k Number | K874194 |
Device Name: | PROTECT DROPS/SAME AS K874070 |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | JOHN O. BUTLER 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
Contact | A Marcouiller |
Correspondent | A Marcouiller JOHN O. BUTLER 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-14 |
Decision Date | 1987-12-16 |