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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K922082
Device Name LAPAROSCOPIC INTRODUCER
Applicant
ENDOMEDIX
2162 MICHELSON DR.
IRVINE,  CA  92715 -1304
Applicant Contact WAYNE R HOHMAN
Correspondent
ENDOMEDIX
2162 MICHELSON DR.
IRVINE,  CA  92715 -1304
Correspondent Contact WAYNE R HOHMAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/04/1992
Decision Date 08/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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