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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Protective, Personnel
510(k) Number K802377
Device Name MOTI PROTECTIVE X-RAY MASK
Applicant
Moti Enterprises, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Moti Enterprises, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.6500
Classification Product Code
KPY  
Date Received09/30/1980
Decision Date 10/31/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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