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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850375
Device Name MICROSURGERY VISIBILITY BACKGROUND MATERIAL
Applicant
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact ROBERT H O'HOLLA
Correspondent
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact ROBERT H O'HOLLA
Date Received01/31/1985
Decision Date 04/08/1985
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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