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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 K931856
Device Name 5.0 MM IRRIGATION/ASPIRATION PROBE
Applicant
MAYAGUEZ MEDICAL CENTER
18 CRESTWOOD DR.
TROPHY CLUB,  TX  76262
Applicant Contact JOHN MAYALL
Correspondent
MAYAGUEZ MEDICAL CENTER
18 CRESTWOOD DR.
TROPHY CLUB,  TX  76262
Correspondent Contact JOHN MAYALL
Regulation Number878.4680
Classification Product Code
GCY  
Date Received04/13/1993
Decision Date 08/10/1993
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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