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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K842626
Device Name HIP PROSTHESIS PACK
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact SUSAN HEVEY
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact SUSAN HEVEY
Date Received07/06/1984
Decision Date 10/24/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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