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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fiber, Medical, Absorbent
510(k) Number K800248
Device Name SURGITEK FOERSTER FACE LIFT BANDAGE
Applicant
Medical Engineering Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Engineering Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5300
Classification Product Code
FRL  
Date Received02/06/1980
Decision Date 02/19/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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