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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K941969
Device Name ENDOPLUS
Applicant
WEMBLEY RUBBER PRODUCTS (M) SDN BHD
KAWASAN PERUSAHAAN BANDAR BARU
LOT 1, JALAN 3
SEPANG SELANGOR,  MY 43900
Applicant Contact ONG GHEE CHEE
Correspondent
WEMBLEY RUBBER PRODUCTS (M) SDN BHD
KAWASAN PERUSAHAAN BANDAR BARU
LOT 1, JALAN 3
SEPANG SELANGOR,  MY 43900
Correspondent Contact ONG GHEE CHEE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/22/1994
Decision Date 06/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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