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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lavage, Jet
510(k) Number K854543
Device Name PULSE LAVAGE
Applicant
Tava Surgical Instruments
7756 Burnett Ave.
Van Nuys,  CA  91405
Applicant Contact TERRY M MATTCHEN
Correspondent
Tava Surgical Instruments
7756 Burnett Ave.
Van Nuys,  CA  91405
Correspondent Contact TERRY M MATTCHEN
Regulation Number880.5475
Classification Product Code
FQH  
Date Received11/13/1985
Decision Date 01/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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