FDA 510(k) Application Details - K030422

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K030422
Device Name Laparoscope, General & Plastic Surgery
Applicant LINA MEDICAL CML APS
FORMERVANGEN 5
GLOSTRUP 2600 DK
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Contact NIELS KORNERUP
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 02/10/2003
Decision Date 04/14/2003
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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