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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 Removal, Ac-Powered
510(k) Number K893380
Device Name QCR SYSTEM I AND QCR SYSTEM II
Applicant
Bremer Mfg. & Tool Co., Inc.
1455 W Fairbanks Ave.
Post Office Box 2894
Winter Park,  FL  32790
Applicant Contact EDWARD LIVINGSTON
Correspondent
Bremer Mfg. & Tool Co., Inc.
1455 W Fairbanks Ave.
Post Office Box 2894
Winter Park,  FL  32790
Correspondent Contact EDWARD LIVINGSTON
Regulation Number888.5960
Classification Product Code
LGH  
Date Received05/01/1989
Decision Date 11/16/1989
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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