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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
510(k) Number K941955
Device Name LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S
Applicant
Lorrex Health Products
301 Penhorn Ave.
Secaucus,  NJ  07094
Applicant Contact ERIC MORALES
Correspondent
Lorrex Health Products
301 Penhorn Ave.
Secaucus,  NJ  07094
Correspondent Contact ERIC MORALES
Classification Product Code
EFQ  
Date Received04/22/1994
Decision Date 05/12/1994
Decision Substantially Equivalent (SESE)
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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