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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Barrier, Protective
510(k) Number K040794
Device Name INCUBATOR CAPE
Applicant
WRAPPED IN COMFORT
15760 VIA SONATA
SAN LORENZO,  CA  94580
Applicant Contact JANE GETSLA
Correspondent
WRAPPED IN COMFORT
15760 VIA SONATA
SAN LORENZO,  CA  94580
Correspondent Contact JANE GETSLA
Regulation Number878.4370
Classification Product Code
MMP  
Date Received03/29/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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