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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 K951418
Device Name LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
Applicant
Lorons International Corp.
301 Penhorn Ave.
Secaucus,  NJ  07094
Applicant Contact DAVID M PIERATOS
Correspondent
Lorons International Corp.
301 Penhorn Ave.
Secaucus,  NJ  07094
Correspondent Contact DAVID M PIERATOS
Classification Product Code
EFQ  
Date Received03/28/1995
Decision Date 04/14/1995
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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