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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 K981531
Device Name SUTURE PLACEMENT DEVICE AND ACCESSORIES
Applicant
Lsi Solutions
2144 Brighton-Henrietta Town
Line Rd.
Rochester,  NY  14623
Applicant Contact JUDE S SAUER
Correspondent
Lsi Solutions
2144 Brighton-Henrietta Town
Line Rd.
Rochester,  NY  14623
Correspondent Contact JUDE S SAUER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/29/1998
Decision Date 07/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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