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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 K881476
Device Name PREEMICARE MODEL D1-X1, SERIES 3000
Applicant
Preemicare Corp.
3300 Walnut Bend Ln.
Houston,  TX  77042
Applicant Contact CHARLES S BOYD
Correspondent
Preemicare Corp.
3300 Walnut Bend Ln.
Houston,  TX  77042
Correspondent Contact CHARLES S BOYD
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received04/07/1988
Decision Date 12/08/1988
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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