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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Cast Application/Removal, Manual
510(k) Number K851786
Device Name 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF
Applicant
Artiberia
4518 Los Ranchitos
San Antonio,  TX  78233
Applicant Contact GIL M SANCHEZ
Correspondent
Artiberia
4518 Los Ranchitos
San Antonio,  TX  78233
Correspondent Contact GIL M SANCHEZ
Regulation Number888.5980
Classification Product Code
LGG  
Date Received04/25/1985
Decision Date 07/09/1985
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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