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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K933901
Device Name REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)
Applicant
Richard-Allan Medical
8850m89, Box 351
Richland,  MI  49083
Applicant Contact JULIE POWELL
Correspondent
Richard-Allan Medical
8850m89, Box 351
Richland,  MI  49083
Correspondent Contact JULIE POWELL
Regulation Number878.4740
Classification Product Code
GAG  
Date Received08/10/1993
Decision Date 11/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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