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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, Angiographic
510(k) Number K002840
Device Name MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM
Applicant
The Phantom Laboratory, Inc.
2727 State Rte. 29
Greenwich,  NY  12834
Applicant Contact JOSHUA R LEVY
Correspondent
The Phantom Laboratory, Inc.
2727 State Rte. 29
Greenwich,  NY  12834
Correspondent Contact JOSHUA R LEVY
Regulation Number892.1600
Classification Product Code
IZI  
Date Received09/12/2000
Decision Date 11/17/2000
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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