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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 K945335
Device Name CHERRY 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 12/28/1994
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
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