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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K920470
Device Name MEYER FOREIGN BODY LOCATOR
Applicant
Seymour W. Meyer
495 E. Shore Rd.
Great Neck,  NY  11024
Applicant Contact SEYMOUR W MEYER
Correspondent
Seymour W. Meyer
495 E. Shore Rd.
Great Neck,  NY  11024
Correspondent Contact SEYMOUR W MEYER
Regulation Number892.1710
Classification Product Code
IZH  
Date Received01/28/1992
Decision Date 08/26/1992
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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