FDA 510(k) Application Details - K001264

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K001264
Device Name Laparoscope, General & Plastic Surgery
Applicant EAGLE ENDOSCOPIC, INC.
700 SEALS RD.
BARTONVILLE, TX 76226 US
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Contact JOHN MAYALL
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 04/19/2000
Decision Date 05/30/2000
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



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