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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K890545
Device Name NU-DERM HYDROCOLLOID DRESSING
Applicant
Johnson & Johnson Patient Care, Inc.
New Brunswick,  NJ  08903
Applicant Contact OMEGA NORTON-CRABLE
Correspondent
Johnson & Johnson Patient Care, Inc.
New Brunswick,  NJ  08903
Correspondent Contact OMEGA NORTON-CRABLE
Classification Product Code
FRO  
Date Received02/03/1989
Decision Date 03/23/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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