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510(k) K912775

SAPPHIRE 4ME EMG/EP SYSTEM by Medelec Intl. Corp. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1991
Date Received
June 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

Other clearances by Medelec Intl. Corp.

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  • K863491 — BLOOD SPECIMEN COLLECTION DEVICES (October 24, 1986)
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  • K854858 — SCALPEL HANDLE (December 24, 1985)
  • K854860 — BLADES, SCALPEL CARBON STEET (December 24, 1985)

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