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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, ac-powered and accessories
510(k) Number K954614
Device Name EOS BRAND DISPOSABLE PROCTOSCOPE
Applicant
NORTH EOS INDUSTRIES, INC.
54, LANE 1, BEEN ST.
P.O. BOX 22, TUNG SHIH
TAICHUNG HSIEN 423,  TW
Applicant Contact SARA CHEN
Correspondent
NORTH EOS INDUSTRIES, INC.
54, LANE 1, BEEN ST.
P.O. BOX 22, TUNG SHIH
TAICHUNG HSIEN 423,  TW
Correspondent Contact SARA CHEN
Regulation Number876.1500
Classification Product Code
GCP  
Date Received10/05/1995
Decision Date 04/10/1996
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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