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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applier, Staple, Surgical,
510(k) Number K933508
Device Name REFLEX SDD SURGICAL STAPLER
Applicant
RICHARD-ALLAN MEDICAL
8850 M89, BOX 351
RICHLAND,  MI  49083 -0351
Applicant Contact JULIE POWELL
Correspondent
RICHARD-ALLAN MEDICAL
8850 M89, BOX 351
RICHLAND,  MI  49083 -0351
Correspondent Contact JULIE POWELL
Regulation Number878.4800
Classification Product Code
GEF  
Date Received07/20/1993
Decision Date 11/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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