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510(k) K953831

N 800 HF by Nucletron-Oldelft Corp. — Product Code IZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
August 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, High-Voltage, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1700
Review Panel
RA
Submission Type

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  • K853912 — MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS (May 21, 1986)
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  • K950041 — SII 360 APR (March 21, 1995)
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  • K950040 — SII 525 APR (March 21, 1995)