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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K842779
Device Name ACT, SUCTION TIP
Applicant
Edward Manougian, M.D.
1517 Summit Rd.
Berkeley,  CA  94708
Correspondent
Edward Manougian, M.D.
1517 Summit Rd.
Berkeley,  CA  94708
Regulation Number868.6810
Classification Product Code
BSY  
Date Received07/16/1984
Decision Date 10/12/1984
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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