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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Pediatric Open Hospital
510(k) Number K860120
Device Name NURSERY AMBIENT LIGHT METER
Applicant
Rocky Mountain Medical Corp.
5680 S. Syracuse Cir.
P.O. Box 4783
Greenwood Village,  CO  80111
Applicant Contact ROSENBAUM MD
Correspondent
Rocky Mountain Medical Corp.
5680 S. Syracuse Cir.
P.O. Box 4783
Greenwood Village,  CO  80111
Correspondent Contact ROSENBAUM MD
Regulation Number880.5140
Classification Product Code
FMS  
Date Received01/13/1986
Decision Date 02/19/1986
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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