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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,Nonresorbable For External Use
510(k) Number K770410
Device Name BANDAGE COMPRESS 2, 3, 4
Applicant
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent
Johnson & Johnson Professionals, Inc.
325 Paramount Dr.
Raynham,  MA  02767 -0350
Regulation Number878.4014
Classification Product Code
NAB  
Date Received03/04/1977
Decision Date 06/09/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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