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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, surgical instrument, disposable
510(k) Number K821500
Device Name STERILE CATH CARE KIT
Applicant
PRO-PAK
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PRO-PAK
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
KDD  
Date Received05/19/1982
Decision Date 06/23/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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