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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K863271
Device Name FASCICULATED S ROD
Applicant
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Applicant Contact WILLIAM X HALLORAN
Correspondent
The Deca Co.
P.O. Box 1997
Costa Mesa,  CA  92626
Correspondent Contact WILLIAM X HALLORAN
Date Received08/25/1986
Decision Date 12/24/1986
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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