FDA 510(k) Application Details - K070102

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K070102
Device Name Laparoscope, General & Plastic Surgery
Applicant SOPRO
124 GAITHER DRIVE
SUITE 140
MT. LAUREL, NJ 08054 US
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Contact STEVE SALESKY
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/10/2007
Decision Date 02/20/2007
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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