FDA 510(k) Application Details - K955076

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K955076
Device Name Laparoscope, General & Plastic Surgery
Applicant PEARSON STRACH MEDICAL
1102 MOCKINGBIRD LN.
KELLER, TX 76248 US
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Contact DENNIS STRACH
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 11/01/1995
Decision Date 04/02/1996
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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