The following data is part of a premarket notification filed by Castle Co. with the FDA for 1500 Eo Exhaust Hood.
Device ID | K792660 |
510k Number | K792660 |
Device Name: | 1500 EO EXHAUST HOOD |
Classification | Sterilizer, Ethylene-oxide Gas |
Applicant | CASTLE CO. 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 | 1979-12-27 |
Decision Date | 1980-01-29 |