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510(k) K000416

TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 by Retinalabs.Com — Product Code MPA

Clearance Details

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

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

Other clearances by Retinalabs.Com

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  • K000420 — SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 (May 8, 2000)

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