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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sucker, cardiotomy return, cardiopulmonary bypass
510(k) Number K801641
Device Name OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT
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 Number870.4420
Classification Product Code
DTS  
Date Received07/17/1980
Decision Date 07/28/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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