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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K883779
Device Name WALLABY(TM) BLANKET
Applicant
Fiberoptic Medical Products, Inc.
3400 Centre Sq. W.
1500 Market St.
Philadelphia,  PA  19102
Applicant Contact JOHN B REISS
Correspondent
Fiberoptic Medical Products, Inc.
3400 Centre Sq. W.
1500 Market St.
Philadelphia,  PA  19102
Correspondent Contact JOHN B REISS
Regulation Number880.5700
Classification Product Code
LBI  
Date Received09/06/1988
Decision Date 11/14/1988
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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