FDA 510(k) Application Details - K941206

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K941206
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant NEW EDER CORP.
1451-E LANDMEIER RD.
ELK GROOVE VILLAGE, IL US
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Contact JAIRO E CANAVERAL
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 03/14/1994
Decision Date 07/25/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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