The following data is part of a premarket notification filed by Sultan Chemists, Inc. with the FDA for Pro-portion Cleaner/disinfectant.
Device ID | K991509 |
510k Number | K991509 |
Device Name: | PRO-PORTION CLEANER/DISINFECTANT |
Classification | Disinfectant, Medical Devices |
Applicant | SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
Contact | Les Heimann |
Correspondent | Les Heimann SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-30 |
Decision Date | 1999-07-14 |
Summary: | summary |