FDA 510(K) K100442, FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
FDA 510(K) K100442, FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K100442
Device Name FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
Applicant SURGICAL INNOVATIONS GROUP PLC
Regulation Number 876.1500
Classification Product Code GCJ
Date Received 02/17/2010
Decision Date 09/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Total pages: 343
Fully redacted pages: 166
Content pages: 177
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