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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 K834384
Device Name MODULAR EXTREMITY CASTING SUPPORT
Applicant
Buckman Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Buckman Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.5980
Classification Product Code
LGG  
Date Received12/14/1983
Decision Date 01/30/1984
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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