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510(k) K821481

NASAL-THROAT SPRAY IRRIGATION INSTRUM. by Ethicare Products — Product Code ETP

K821481 is an FDA 510(k) premarket notification submitted by Ethicare Products for the device "NASAL-THROAT SPRAY IRRIGATION INSTRUM.". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code ETP (Stimulator, Caloric-Water), a Class I device regulated under 21 CFR 874.1800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
May 18, 1982
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

Other clearances for product code ETP

  • K863615 — ENTHERMO IRRIGATION UNIT (December 16, 1986)
  • K820775 — VESTIBULARISET (November 3, 1982)
  • K813552 — MODEL 3000C CALORIC IRRIGATOR (February 22, 1982)
  • K800442 — VARIOTHERM (March 10, 1980)
  • K800443 — HYGROTHERM (March 10, 1980)

FDA data resources