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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 K860981
Device Name ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM
Applicant
SUN TECHNOLOGIES
2011, 5TH ST.
SUITE #5
TEMPE,  AZ  85281
Applicant Contact MICHAEL FARKAS
Correspondent
SUN TECHNOLOGIES
2011, 5TH ST.
SUITE #5
TEMPE,  AZ  85281
Correspondent Contact MICHAEL FARKAS
Regulation Number878.4680
Classification Product Code
GCY  
Date Received03/14/1986
Decision Date 05/02/1986
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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