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510(k) K931882

MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR by Alphatek Corp. — Product Code IXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1993
Date Received
April 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Radiographic-Film, Automatic
Device Class
Class II
Regulation Number
892.1900
Review Panel
RA
Submission Type

Other clearances by Alphatek Corp.

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  • K925569 — AX-700LE AUTOMATIC X-RAY FILM PROCESSOR (January 15, 1993)
  • K924430 — AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 (November 27, 1992)

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