The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Chemdi.
Device ID | K801428 |
510k Number | K801428 |
Device Name: | CHEMDI |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | AMERICAN STERILIZER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-17 |
Decision Date | 1980-08-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CHEMDI 73073142 1046200 Live/Registered |
AMERICAN STERILIZER COMPANY 1975-12-31 |