The following data is part of a premarket notification filed by Cathra International, Inc. with the FDA for Stock Antimicrobic Solutions.
Device ID | K810471 |
510k Number | K810471 |
Device Name: | STOCK ANTIMICROBIC SOLUTIONS |
Classification | Solution, Antimicrobial |
Applicant | CATHRA INTERNATIONAL, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | LOP |
Subsequent Product Code | New |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-23 |
Decision Date | 1981-04-01 |