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FDA 510(k)

WATER IRRIGATOR, W1 200

K-Number: K941325 · 1994-08-09

ApplicantStrong Medical, Inc.
Decision Date1994-08-09
Product CodeKHH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

WATER IRRIGATOR, W1 200 is the device name listed in this FDA 510(k) record. The listed applicant is Strong Medical, Inc.. It received FDA 510(k) clearance on 1994-08-09 under 510(k) number K941325. The device is classified under product code KHH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATER IRRIGATOR, W1 200?

WATER IRRIGATOR, W1 200 is a medical device that received FDA 510(k) clearance on 1994-08-09. The listed applicant is Strong Medical, Inc.. The 510(k) number is K941325.

When did WATER IRRIGATOR, W1 200 receive FDA 510(k) clearance?

WATER IRRIGATOR, W1 200 received FDA 510(k) clearance on 1994-08-09, under 510(k) number K941325.

Who is the listed applicant for WATER IRRIGATOR, W1 200?

The FDA 510(k) record lists Strong Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WATER IRRIGATOR, W1 200?

The FDA product code for WATER IRRIGATOR, W1 200 is KHH.

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Related Devices (Code: KHH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950785HORTMANN AIRMATIC AIR CALORIC STIMULATORJedmed Instrument Co.K946108EAR-A-GATORLife-Tech Intl., Inc.K931608NCA-200Ics Medical Corp.K925237AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.K881630AUTOMATIC CALORIC IRRIGATION SYSTEMIcs Medical Corp.K822179FRENZEL EYEGLASSES & RELATED ITEMSKelleher Corp.

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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