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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864805
Device Name CLOWARD SURGICAL SADDLE
Applicant
Surgical Equipment International, Inc.
1670 Halekoa Dr.
Honolulu,  HI  96821
Applicant Contact KERRY B CLOWARD
Correspondent
Surgical Equipment International, Inc.
1670 Halekoa Dr.
Honolulu,  HI  96821
Correspondent Contact KERRY B CLOWARD
Date Received12/09/1986
Decision Date 12/24/1986
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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