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FDA 510(k)

ZEROWET SPLASHIELD

K-Number: K900208 · 1990-09-04

Decision Date1990-09-04
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZEROWET SPLASHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Zerowet Splashield. It received FDA 510(k) clearance on 1990-09-04 under 510(k) number K900208. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEROWET SPLASHIELD?

ZEROWET SPLASHIELD is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Zerowet Splashield. The 510(k) number is K900208.

When did ZEROWET SPLASHIELD receive FDA 510(k) clearance?

ZEROWET SPLASHIELD received FDA 510(k) clearance on 1990-09-04, under 510(k) number K900208.

Who is the listed applicant for ZEROWET SPLASHIELD?

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

What is the FDA product code for ZEROWET SPLASHIELD?

The FDA product code for ZEROWET SPLASHIELD is KYZ.

Related Clinical Trials

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.

Related Devices (Code: KYZ)

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.

Official Source

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

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