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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 K833586
Device Name TLS BULB DRAINAGE SYSTEM
Applicant
POREX MEDICAL
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
POREX MEDICAL
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4680
Classification Product Code
GCY  
Date Received10/12/1983
Decision Date 01/30/1984
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
Recalls CDRH Recalls
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