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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Denture, Karaya
510(k) Number K802285
Device Name OHIO THORACIC SUCTION REGULATOR
Applicant
Ohio Medical Products
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ohio Medical Products
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3450
Classification Product Code
KOP  
Date Received09/19/1980
Decision Date 10/03/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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