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510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) NumberK011016
Device NameLSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
Applicant
LSI SOLUTIONS
2144 brighton-henrietta town
line rd.
rochester,  NY  14623
Contactchristine e ehmann
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/04/2001
Decision Date 04/27/2001
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Summary/purged 510(k)
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
 
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