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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 K883229
Device Name OHMEDA CONTINUOUS SUCTION REGULATOR
Applicant
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Applicant Contact ALBERTO F PROFUMO
Correspondent
Ohmeda Medical
9065 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact ALBERTO F PROFUMO
Regulation Number880.6740
Classification Product Code
KDP  
Date Received08/01/1988
Decision Date 10/19/1988
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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