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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 K922618
Device Name BOWRON
Applicant
G.L. Bowron & Co. , Ltd.
P.O. Box 151
Bellingham,  MA  02019
Applicant Contact GEORGE F COUGHLIN
Correspondent
G.L. Bowron & Co. , Ltd.
P.O. Box 151
Bellingham,  MA  02019
Correspondent Contact GEORGE F COUGHLIN
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received06/02/1992
Decision Date 08/19/1993
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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