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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crutch
510(k) Number K821403
Device Name LIGHT WEIGHT ALUMINUM CRUTCHES
Applicant
Manuco Manufacturing Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Manuco Manufacturing Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.3150
Classification Product Code
IPR  
Date Received05/11/1982
Decision Date 06/21/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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