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510(k) K950566

DECOMAT 4656 by Getinge Disinfection, Inc. — Product Code LDS

K950566 is an FDA 510(k) premarket notification submitted by Getinge Disinfection, Inc. for the device "DECOMAT 4656". The FDA issued a decision of Substantially Equivalent on October 19, 1995. The device falls under product code LDS (Device, Pasteurization, Hot Water), a Class II device regulated under 21 CFR 880.6991.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1995
Date Received
February 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Pasteurization, Hot Water
Device Class
Class II
Regulation Number
880.6991
Review Panel
HO
Submission Type

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  • K844089 — CASTLE 7515 UTENSIL/GLASSWARE WASHER (January 14, 1985)
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FDA data resources