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510(k) K060550

KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 by Eastman Kodak Company — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2006
Date Received
March 2, 2006
Clearance Type
Special
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

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  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K040556 — TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY (April 7, 2004)

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