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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 K874504
Device Name MICRO-AIRE PULSE LAVAGE
Applicant
Micro-Aire Surgical Instruments, Inc.
505 Fourth St.
San Fernando,  CA  91340
Applicant Contact SIDDHARTH DESAI
Correspondent
Micro-Aire Surgical Instruments, Inc.
505 Fourth St.
San Fernando,  CA  91340
Correspondent Contact SIDDHARTH DESAI
Regulation Number880.5475
Classification Product Code
FQH  
Date Received11/02/1987
Decision Date 12/29/1987
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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