The following data is part of a premarket notification filed by Castle Co. with the FDA for Castle 7515 Utensil/glassware Washer.
Device ID | K844089 |
510k Number | K844089 |
Device Name: | CASTLE 7515 UTENSIL/GLASSWARE 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 | 1984-10-22 |
Decision Date | 1985-01-14 |