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510(k) K000418

PDT DOSECALCULATOR, MODEL 80000 by Retinalabs.Com — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2000
Date Received
February 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

Other clearances by Retinalabs.Com

  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
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  • K000416 — TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 (May 8, 2000)
  • K000420 — SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 (May 8, 2000)

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