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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal
510(k) Number K915752
Device Name FIRST TOUCH/VILEDON NON-WOVEN FILTER
Applicant
First Touch Disposables, Inc.
3342 Wrightville Ave.
Wilmington,  NC  28403
Applicant Contact DEVITA II
Correspondent
First Touch Disposables, Inc.
3342 Wrightville Ave.
Wilmington,  NC  28403
Correspondent Contact DEVITA II
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received12/23/1991
Decision Date 09/17/1992
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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