FDA 510(k) Application Details - K150253

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K150253
Device Name Laparoscope, General & Plastic Surgery
Applicant TAIWAN SURGICAL CORPORATION
3F., No. 12. Sec 2, ShengYi Rd.
Zhubei City 30261 TW
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Contact HSIU-PING HUANG
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 02/03/2015
Decision Date 04/01/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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