FDA 510(k) Application Details - K000202

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K000202
Device Name Laparoscope, General & Plastic Surgery
Applicant CORTEK ENDOSCOPY, INC.
501 W. COLFAX, SUITE B
PALATINE, IL 60067 US
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Contact CORNEL M TOPALA
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/21/2000
Decision Date 03/31/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K000202


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