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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K812482
Device Name FOAM WEDGE
Applicant
Maddak, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Maddak, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LDQ
Date Received08/31/1981
Decision Date 09/24/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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