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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 K945332
Device Name ROSEBUD DISSECTOR
Applicant
Lorrex Health Products
301 Penhorn Ave.
Secaucus,  NJ  07094
Applicant Contact DAVID M PIERATOS
Correspondent
Lorrex Health Products
301 Penhorn Ave.
Secaucus,  NJ  07094
Correspondent Contact DAVID M PIERATOS
Regulation Number878.4450
Classification Product Code
GDY  
Date Received11/01/1994
Decision Date 12/05/1994
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
Predetermined Change
Control Plan Authorized		 No
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