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510(k) K001544

VAGINAL APPLICATOR SHIELDED by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2000
Date Received
May 18, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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