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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressings Containing Topical Analgesics
510(k) Number K001023
Device Name FREEDOM, MODEL 4660
Applicant
Johnson & Johnson Consumer Companies, Inc.
199 Grandview Rd.
Skillman,  NJ  08558 -9498
Applicant Contact JOSEPH KICEINA
Correspondent
Johnson & Johnson Consumer Companies, Inc.
199 Grandview Rd.
Skillman,  NJ  08558 -9498
Correspondent Contact JOSEPH KICEINA
Classification Product Code
SEJ  
Date Received03/30/2000
Decision Date 09/22/2000
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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