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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 K821814
Device Name HEMO-NATE L-P KIT
Applicant
Int'L Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Int'L Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
KDD  
Date Received06/18/1982
Decision Date 07/09/1982
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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