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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drain, Tee (Water Trap)
510(k) Number K853665
Device Name SPLASH ADAPTOR
Applicant
Ohio Medical Research, Inc.
4353 Monroe St.
Toledo,  OH  43606
Applicant Contact ROBERT E DUNLAP
Correspondent
Ohio Medical Research, Inc.
4353 Monroe St.
Toledo,  OH  43606
Correspondent Contact ROBERT E DUNLAP
Regulation Number868.5995
Classification Product Code
BYH  
Date Received09/03/1985
Decision Date 10/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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