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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K801127
Device Name MACROVAC
Applicant
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Applicant Contact Alfred A Iversen
Correspondent
Progress Mankind Technology
Box 464
Hopkins,  MN  55343
Correspondent Contact Alfred A Iversen
Regulation Number880.6740
Classification Product Code
JOL  
Date Received05/12/1980
Decision Date 05/30/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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