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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854068
Device Name EXTERNAL MECHANICAL FASTENER
Applicant
Wells Johnson Co.
2045 # Forbes Blvd., Suite 106
Tucson,  AZ  85745
Applicant Contact JOHN JOHNSON
Correspondent
Wells Johnson Co.
2045 # Forbes Blvd., Suite 106
Tucson,  AZ  85745
Correspondent Contact JOHN JOHNSON
Date Received10/04/1985
Decision Date 11/22/1985
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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