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510(k) K964743

STORZ E8010 ERGOTEC/PREMIERE ADAPTOR by Storz Instrument Co. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1997
Date Received
November 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

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  • K961831 — STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK (August 6, 1996)

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