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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, battery-powered and accessories
510(k) Number K921006
Device Name LAPAROSCOPIC RETRACTOR SYSTEM
Applicant
LAPAROMED CORP.
9272 JERONIMO RD., UNIT 109
IRVINE,  CA  92718
Applicant Contact PAUL LUBOCK
Correspondent
LAPAROMED CORP.
9272 JERONIMO RD., UNIT 109
IRVINE,  CA  92718
Correspondent Contact PAUL LUBOCK
Regulation Number876.1500
Classification Product Code
GCS  
Date Received03/03/1992
Decision Date 07/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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