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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 K011016
Device Name LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
Applicant
LSI SOLUTIONS
2144 brighton-henrietta town
line rd.
rochester,  NY  14623
Applicant Contact christine e ehmann
Correspondent
LSI SOLUTIONS
2144 brighton-henrietta town
line rd.
rochester,  NY  14623
Correspondent Contact christine e ehmann
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/04/2001
Decision Date 04/27/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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