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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 K905733
Device Name SEROMA-CATH CLOSE DRAINAGE SYSTEM
Applicant
DAWN MEDICAL
210 SAN BENITO WAY
SAN FRANCISCO,  CA  94127
Applicant Contact BRUCE FITZGERALD
Correspondent
DAWN MEDICAL
210 SAN BENITO WAY
SAN FRANCISCO,  CA  94127
Correspondent Contact BRUCE FITZGERALD
Regulation Number878.4680
Classification Product Code
GCY  
Date Received12/24/1990
Decision Date 01/28/1991
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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