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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Hand, And Components
510(k) Number K810109
Device Name METAL SPLINTS
Applicant
SECOL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SECOL CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number890.3475
Classification Product Code
ILH  
Date Received01/16/1981
Decision Date 01/26/1981
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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