FDA 510(k)

MODEL 3000C CALORIC IRRIGATOR

K-Number: K813552 · 1982-02-22

Decision Date1982-02-22

Product CodeETP

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

MODEL 3000C CALORIC IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1982-02-22 under 510(k) number K813552. The device is classified under product code ETP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 3000C CALORIC IRRIGATOR?

MODEL 3000C CALORIC IRRIGATOR is a medical device that received FDA 510(k) clearance on 1982-02-22. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K813552.

When did MODEL 3000C CALORIC IRRIGATOR receive FDA 510(k) clearance?

MODEL 3000C CALORIC IRRIGATOR received FDA 510(k) clearance on 1982-02-22, under 510(k) number K813552.

Who is the listed applicant for MODEL 3000C CALORIC IRRIGATOR?

The FDA 510(k) record lists Life-Tech Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 3000C CALORIC IRRIGATOR?

The FDA product code for MODEL 3000C CALORIC IRRIGATOR is ETP.

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Other records listing Life-Tech Intl., Inc. as applicant

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Related Devices (Code: ETP)

K863615ENTHERMO IRRIGATION UNITJedmed Instrument Co.K820775VESTIBULARISETJedmed Instrument Co.K821481NASAL-THROAT SPRAY IRRIGATION INSTRUM.Ethicare Products K800443HYGROTHERMJedmed Instrument Co.K800442VARIOTHERMJedmed Instrument Co.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.