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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K944435
Device Name DOSPOSABLE ENOSCOPIC HERNIA SURGICAL STAPLER
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number876.1500
Classification Product Code
OCW  
Date Received09/12/1994
Decision Date 11/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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