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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K030061
Device Name PS 3000 DIGATAL PHOTOSPOT SYSTEM
Applicant
Precise Optics
1151 Hope St.
Stamford,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
Precise Optics
1151 Hope St.
Stamford,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received01/07/2003
Decision Date 04/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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