1075LD HUSH-SLUSH

Warmer, Irrigation Solution

O.R. SOLUTIONS, INC.

The following data is part of a premarket notification filed by O.r. Solutions, Inc. with the FDA for 1075ld Hush-slush.

Pre-market Notification Details

Device IDK023283
510k NumberK023283
Device Name:1075LD HUSH-SLUSH
ClassificationWarmer, Irrigation Solution
Applicant O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR. SUITE W Chantilly,  VA  20151 -1689
ContactSteve Hannes
CorrespondentSteve Hannes
O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR. SUITE W Chantilly,  VA  20151 -1689
Product CodeLHC  
CFR Regulation Number890.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-01
Decision Date2002-11-13

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