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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K901434
Device Name PAPILLOTOME
Applicant
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Applicant Contact JOHN A CHAVES
Correspondent
Telemed Systems, Inc.
8 Kane Industrial Dr.
Hudson,  MA  01749
Correspondent Contact JOHN A CHAVES
Regulation Number888.3660
Classification Product Code
KWS  
Date Received03/26/1990
Decision Date 06/08/1990
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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