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510(k) K904726

LYTENING TM 6/R by Amdev, Inc. — Product Code JFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1990
Date Received
October 17, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Amdev, Inc.

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  • K880917 — LYTENING 5 (May 27, 1988)
  • K863521 — LYTENING 2 (November 5, 1986)
  • K853832 — LYTENING 1 (October 4, 1985)

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