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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, Fluoroscopic, Image-Intensified
510(k) Number K973073
Device Name DRTS IMAGE INTENSIFIER DRAPE
Applicant
Minrad, Inc.
6576 E. Quaker St.
Orchard Park,  NY  14127
Applicant Contact JOHN MCNEIRNEY
Correspondent
Minrad, Inc.
6576 E. Quaker St.
Orchard Park,  NY  14127
Correspondent Contact JOHN MCNEIRNEY
Regulation Number892.1650
Classification Product Code
JAA  
Date Received08/18/1997
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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