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FDA 510(k), K111495, COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
FDA 510(k), K111495, COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
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510(K) Number: K111495
Device Name: COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
Manufacturer: WILSON-COOK MEDICAL INC.
Device Classification Name: endoscopic injection needle, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FBK
Date Received: 05/31/2011
Decision Date: 07/19/2011
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
Manufacturer: WILSON-COOK MEDICAL INC.
Device Classification Name: endoscopic injection needle, gastroenterology-urology
Regulation Number: 876.1500
Classification Product Code: FBK
Date Received: 05/31/2011
Decision Date: 07/19/2011
Regulation Medical Specialty: Gastroenterology/Urology
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