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510(k) K921961

SDMO APPLICATOR CODE: ASN.8236 by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code IWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1992
Date Received
April 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Manual
Device Class
Class I
Regulation Number
892.5650
Review Panel
RA
Submission Type

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