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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 K934527
Device Name FASCIA STITCHER
Applicant
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Applicant Contact PAUL LUBLOCK
Correspondent
Laparomed Corp.
9272 Jeronimo Rd., Unit 109
Irvine,  CA  92718
Correspondent Contact PAUL LUBLOCK
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HET  
Date Received09/20/1993
Decision Date 02/25/1994
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
Predetermined Change
Control Plan Authorized		 No
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