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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, automatic carbon-dioxide for endoscope
510(k) Number K930508
Device Name HIFLO FILTERED INSUFFLATION TUBING
Applicant
W. J. MEDICAL INSTRUMENTS, INC.
3537 OLD CONEJO RD.
SUITE 109
NEWBURY PARK,  CA  91320
Applicant Contact WILLIAM ZINNANTI
Correspondent
W. J. MEDICAL INSTRUMENTS, INC.
3537 OLD CONEJO RD.
SUITE 109
NEWBURY PARK,  CA  91320
Correspondent Contact WILLIAM ZINNANTI
Regulation Number876.1500
Classification Product Code
FCX  
Date Received02/01/1993
Decision Date 06/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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