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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, ear
510(k) Number K891269
Device Name MICROTRAK EIA AUTOWASHER
Applicant
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Applicant Contact ROGERS, JR.
Correspondent
SYVA CO.
900 ARASTRADERO RD.
P.O. BOX 10058
PALO ALTO,  CA  94303
Correspondent Contact ROGERS, JR.
Regulation Number878.4800
Classification Product Code
JYC  
Date Received03/09/1989
Decision Date 05/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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