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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauze/sponge, internal, x-ray detectable
510(k) Number K953830
Device Name KENSORB
Applicant
KENTRON HEALTH CARE, INC.
4330 SHERIDAN ST.
HOLLYWOOD,  FL  33021
Applicant Contact NARI SADARANGANI
Correspondent
KENTRON HEALTH CARE, INC.
4330 SHERIDAN ST.
HOLLYWOOD,  FL  33021
Correspondent Contact NARI SADARANGANI
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/16/1995
Decision Date 10/03/1995
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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