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FDA 510(k)

DRAPE, SURGICAL - UTILITY DRAPE - STERILE

K-Number: K903726 · 1990-08-27

ApplicantGraham Medical Products
Decision Date1990-08-27
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPE, SURGICAL - UTILITY DRAPE - STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Graham Medical Products. It received FDA 510(k) clearance on 1990-08-27 under 510(k) number K903726. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAPE, SURGICAL - UTILITY DRAPE - STERILE?

DRAPE, SURGICAL - UTILITY DRAPE - STERILE is a medical device that received FDA 510(k) clearance on 1990-08-27. The listed applicant is Graham Medical Products. The 510(k) number is K903726.

When did DRAPE, SURGICAL - UTILITY DRAPE - STERILE receive FDA 510(k) clearance?

DRAPE, SURGICAL - UTILITY DRAPE - STERILE received FDA 510(k) clearance on 1990-08-27, under 510(k) number K903726.

Who is the listed applicant for DRAPE, SURGICAL - UTILITY DRAPE - STERILE?

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

What is the FDA product code for DRAPE, SURGICAL - UTILITY DRAPE - STERILE?

The FDA product code for DRAPE, SURGICAL - UTILITY DRAPE - STERILE is KKX.

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Other records listing Graham Medical Products 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.

K921657VASECTOMY DRAPEK922100DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILEK922059DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599K913448DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILEK913447DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599K913560STOPCOCK

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Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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