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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Endoscopic Suturing
510(k) Number K905722
Device Name SUTURE APPLIER DEVICE
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
MFJ  
Date Received12/20/1990
Decision Date 03/14/1991
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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