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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850251
Device Name ROTALOK SURGICAL HAND TABLE
Applicant
Fairleigh Dickinson Laboratories, Inc.
6 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact GEORGE E KING
Correspondent
Fairleigh Dickinson Laboratories, Inc.
6 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact GEORGE E KING
Date Received01/22/1985
Decision Date 02/28/1985
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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