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510(k) K974597

ADC COMPACT (AGFA DIAGNOSTIC CENTER) by Bayer Corp., Agfa Div. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1998
Date Received
December 9, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Bayer Corp., Agfa Div.

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  • K964414 — LR 5200 LASER FILM RECORDER (January 27, 1997)

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