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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Constrained, Polymer
510(k) Number K820813
Device Name LESSER METATARSAL PHALANG. JOINT PROSTH
Applicant
Sutter Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sutter Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3720
Classification Product Code
KWH  
Date Received03/23/1982
Decision Date 05/21/1982
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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