The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Castle #3241 Gas Aerator.
Device ID | K813201 |
510k Number | K813201 |
Device Name: | CASTLE #3241 GAS AERATOR |
Classification | Cabinet, Ethylene-oxide Gas Aerator |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLI |
CFR Regulation Number | 880.6100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-13 |
Decision Date | 1981-12-31 |