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FDA 510(k)

SPLASH GUARD

K-Number: K905173 · 1991-04-25

ApplicantE.M. Adams
Decision Date1991-04-25
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPLASH GUARD is the device name listed in this FDA 510(k) record. The listed applicant is E.M. Adams. It received FDA 510(k) clearance on 1991-04-25 under 510(k) number K905173. 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 SPLASH GUARD?

SPLASH GUARD is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is E.M. Adams. The 510(k) number is K905173.

When did SPLASH GUARD receive FDA 510(k) clearance?

SPLASH GUARD received FDA 510(k) clearance on 1991-04-25, under 510(k) number K905173.

Who is the listed applicant for SPLASH GUARD?

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

What is the FDA product code for SPLASH GUARD?

The FDA product code for SPLASH GUARD 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.

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Other records listing E.M. Adams as applicant

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.

K910468STERILE DISPOSABLE DRAPE(S)K873978DISPOSABLE BIPOLAR FORCEPSK850063INSTRUMENT POCKETK843724I.V. START KIT & OBSTETRICAL KITK843783WET PACKK843782DRY TRAY

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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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, Inc.

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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