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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Sacroiliac, Soft
510(k) Number K811176
Device Name TIGGES SPINAL
Applicant
The Tiggs Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Tiggs Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3490
Classification Product Code
IPW  
Date Received04/28/1981
Decision Date 05/15/1981
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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