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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K853295
Device Name EMODREN EXCHANGEABLE PLASTIC BELLOWS
Applicant
PAREXEL INTL. CORP.
55 WHEELER ST.
CAMBRIDGE,  MA  02138
Applicant Contact JULIAN P KAYE
Correspondent
PAREXEL INTL. CORP.
55 WHEELER ST.
CAMBRIDGE,  MA  02138
Correspondent Contact JULIAN P KAYE
Regulation Number878.4680
Classification Product Code
GCY  
Date Received08/06/1985
Decision Date 08/20/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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