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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Neonatal Eye
510(k) Number K813214
Device Name INFANT PHOTOTHERAPY MASK
Applicant
Montrose Phototherapy Supply
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Montrose Phototherapy Supply
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5270
Classification Product Code
FOK  
Date Received11/09/1981
Decision Date 12/09/1981
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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