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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Vacuum
510(k) Number K801169
Device Name OHIO FREE FLOW VACUUM REGULATOR
Applicant
Ohio Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ohio Medical Products
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
KDP  
Date Received05/15/1980
Decision Date 07/28/1980
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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