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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, steel, monofilament and multifilament, sterile
510(k) Number K913155
Device Name LEG URINAL
Applicant
EZMT VALVE CO., INC.
22260 DAVENRICH ST.
SALINAS,  CA  93908
Applicant Contact RAYMOND E GRIFFIN
Correspondent
EZMT VALVE CO., INC.
22260 DAVENRICH ST.
SALINAS,  CA  93908
Correspondent Contact RAYMOND E GRIFFIN
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received07/17/1991
Decision Date 09/16/1991
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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