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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Manual
510(k) Number K903403
Device Name CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
Applicant
University of Michigan
Uh-B2c490, Box 0010
1500 E. Medical Center Dr.
Ann Arbor,  MI  48109
Applicant Contact SONJA L SCHOEPPEL
Correspondent
University of Michigan
Uh-B2c490, Box 0010
1500 E. Medical Center Dr.
Ann Arbor,  MI  48109
Correspondent Contact SONJA L SCHOEPPEL
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received07/31/1990
Decision Date 10/01/1990
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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