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FDA 510(k)

HEAD SHEET

K-Number: K931455 · 1994-05-05

ApplicantCustom Medical Products, Ltd.
Decision Date1994-05-05
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEAD SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Products, Ltd.. It received FDA 510(k) clearance on 1994-05-05 under 510(k) number K931455. 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 HEAD SHEET?

HEAD SHEET is a medical device that received FDA 510(k) clearance on 1994-05-05. The listed applicant is Custom Medical Products, Ltd.. The 510(k) number is K931455.

When did HEAD SHEET receive FDA 510(k) clearance?

HEAD SHEET received FDA 510(k) clearance on 1994-05-05, under 510(k) number K931455.

Who is the listed applicant for HEAD SHEET?

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

What is the FDA product code for HEAD SHEET?

The FDA product code for HEAD SHEET is KKX.

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Other records listing Custom Medical Products, Ltd. 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.

K931417STERILE EQUIPMENT COVERSK931456SURGICAL DRAPE AND GOWN TRAYK930815ABDOMINAL / THORACIC PATIENT DRAPEK931418SURGICAL DRAPEK931844CUSTOM PROCEDURE MEDICAL TRAY OR KITK926519SURGICAL GOWN

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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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