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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K863964
Device Name LIMB-GUARD
Applicant
Sparco, Inc.
P.O. Box 20369
Castro Valley,  CA  94546
Applicant Contact BEVERLY J SPARKS
Correspondent
Sparco, Inc.
P.O. Box 20369
Castro Valley,  CA  94546
Correspondent Contact BEVERLY J SPARKS
Date Received10/10/1986
Decision Date 10/24/1986
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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