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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, esophageal motility, anorectal motility, and tube
510(k) Number K922553
Device Name CLA-COMPUTERIZED LARYNGEAL ANALYZER
Applicant
H.I.L. RESEARCH, LTD.
3407 BAY AVE.
CHICO,  CA  95926
Applicant Contact FRANK FERGUSON
Correspondent
H.I.L. RESEARCH, LTD.
3407 BAY AVE.
CHICO,  CA  95926
Correspondent Contact FRANK FERGUSON
Regulation Number876.1725
Classification Product Code
KLA  
Date Received05/29/1992
Decision Date 08/23/1994
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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