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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Utensil, Eating
510(k) Number K833177
Device Name GLOSSECTOMY FEEDING SPOONS
Applicant
Maddak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Maddak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5050
Classification Product Code
ILC  
Date Received09/19/1983
Decision Date 10/31/1983
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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