The following data is part of a premarket notification filed by Castle Co. with the FDA for Castle 7538 Floor Loading Washer.
Device ID | K860263 |
510k Number | K860263 |
Device Name: | CASTLE 7538 FLOOR LOADING WASHER |
Classification | Device, Pasteurization, Hot Water |
Applicant | CASTLE CO. C/O NIXON,HARGRAVE,DEVAN,DOYLE ONE THOMAS CIRCLE, SUITE 800 Washington, DC 20005 |
Contact | Stephen Kurzman |
Correspondent | Stephen Kurzman CASTLE CO. C/O NIXON,HARGRAVE,DEVAN,DOYLE ONE THOMAS CIRCLE, SUITE 800 Washington, DC 20005 |
Product Code | LDS |
CFR Regulation Number | 880.6991 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-27 |
Decision Date | 1986-03-05 |