FDA 510(k) Application Details - K970988

Device Classification Name Accessory, Surgical Apparel

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510(K) Number K970988
Device Name Accessory, Surgical Apparel
Applicant FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD
196 LUOYU ROAD
WUHAN 430079 P.R CN
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Contact PING JIANG
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Regulation Number 878.4040

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Classification Product Code LYU
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Date Received 03/18/1997
Decision Date 07/10/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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