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FDA 510(k)

WATER W/TWEEN 80

K-Number: K834316 · 1984-01-13

ApplicantHardy Media
Decision Date1984-01-13
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WATER W/TWEEN 80 is the device name listed in this FDA 510(k) record. The listed applicant is Hardy Media. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K834316. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATER W/TWEEN 80?

WATER W/TWEEN 80 is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Hardy Media. The 510(k) number is K834316.

When did WATER W/TWEEN 80 receive FDA 510(k) clearance?

WATER W/TWEEN 80 received FDA 510(k) clearance on 1984-01-13, under 510(k) number K834316.

Who is the listed applicant for WATER W/TWEEN 80?

The FDA 510(k) record lists Hardy Media as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WATER W/TWEEN 80?

The FDA product code for WATER W/TWEEN 80 is JSM.

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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.

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