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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 K936223
Device Name PRESSURE IRRIGATING SYSTEM
Applicant
LEVEL 1 TECHNOLOGIES, INC.
160 WEYMOUTH ST.
ROCKLAND,  MA  02370
Applicant Contact ALLAN J PULSIFER
Correspondent
LEVEL 1 TECHNOLOGIES, INC.
160 WEYMOUTH ST.
ROCKLAND,  MA  02370
Correspondent Contact ALLAN J PULSIFER
Regulation Number878.4680
Classification Product Code
GCY  
Date Received12/29/1993
Decision Date 05/12/1994
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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