The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Castle Microcomputer Sterilizer Control.
Device ID | K820783 |
510k Number | K820783 |
Device Name: | CASTLE MICROCOMPUTER STERILIZER CONTROL |
Classification | Sterilizer, Ethylene-oxide Gas |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLF |
CFR Regulation Number | 880.6860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-23 |
Decision Date | 1982-04-15 |