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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bandage, Cast
510(k) Number K800749
Device Name IPOCON 7
Applicant
IPOS LUNEBURG
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IPOS LUNEBURG
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number890.3025
Classification Product Code
ITG  
Date Received04/04/1980
Decision Date 07/28/1980
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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