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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K161209
Device Name Cirona 6400
Applicant
Devon Medical Products
1100 First Ave.
King Of Prussia,  PA  19119
Applicant Contact ROCCO BRAVOCO
Correspondent
Devon Medical Products
1100 First Ave.
King Of Prussia,  PA  19119
Correspondent Contact ROCCO BRAVOCO
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/28/2016
Decision Date 05/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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