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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K913363
Device Name CUSTOM TUBING PACKS
Applicant
Kroy Medical, Inc.
177 Neal Ave. N.
Stillwater,  MN  55082
Applicant Contact JEFFREY P SITES
Correspondent
Kroy Medical, Inc.
177 Neal Ave. N.
Stillwater,  MN  55082
Correspondent Contact JEFFREY P SITES
Regulation Number870.4290
Classification Product Code
DTL  
Date Received07/29/1991
Decision Date 12/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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