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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, X-Ray, Diagnostic
510(k) Number K914184
Device Name P2020-8-0 BEAM-LIMITING DEVICE
Applicant
Precise Optics
239 S. Fehr Way
Bay Shore,  NY  11706
Applicant Contact JOHN D MARCO
Correspondent
Precise Optics
239 S. Fehr Way
Bay Shore,  NY  11706
Correspondent Contact JOHN D MARCO
Regulation Number892.1610
Classification Product Code
KPW  
Date Received09/18/1991
Decision Date 11/27/1991
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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