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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 K945970
Device Name INSUFFLATOR FILTER TUBING SET
Applicant
XYLOG CORP.
83 HOBART ST.
HACKENSACK,  NJ  07601
Applicant Contact SAMUEL DICKSTEIN
Correspondent
XYLOG CORP.
83 HOBART ST.
HACKENSACK,  NJ  07601
Correspondent Contact SAMUEL DICKSTEIN
Regulation Number876.1500
Classification Product Code
FCX  
Date Received12/08/1994
Decision Date 12/15/1994
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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