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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Subtalar, Plug, Polymer
510(k) Number K922292
Device Name LUNDEEN SUBTALAR PEG IMPLANT
Applicant
Sgarlato Laboratories, Inc.
100 O'Connor Dr., Suite 18
San Jose,  CA  95128
Applicant Contact THOMAS E SGARLATO
Correspondent
Sgarlato Laboratories, Inc.
100 O'Connor Dr., Suite 18
San Jose,  CA  95128
Correspondent Contact THOMAS E SGARLATO
Regulation Number888.3040
Classification Product Code
MJW  
Date Received05/15/1992
Decision Date 10/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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