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510(k) K813552

MODEL 3000C CALORIC IRRIGATOR by Life-Tech Intl., Inc. — Product Code ETP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1982
Date Received
December 21, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Caloric-Water
Device Class
Class I
Regulation Number
874.1800
Review Panel
EN
Submission Type

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Other clearances for product code ETP

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  • K800442 — VARIOTHERM (March 10, 1980)
  • K800443 — HYGROTHERM (March 10, 1980)