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FDA 510(k)

THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE

K-Number: K963675 · 1997-01-27

ApplicantMicro-Medical Devices, Inc.
Decision Date1997-01-27
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Medical Devices, Inc.. It received FDA 510(k) clearance on 1997-01-27 under 510(k) number K963675. 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 THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE?

THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Micro-Medical Devices, Inc.. The 510(k) number is K963675.

When did THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE receive FDA 510(k) clearance?

THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE received FDA 510(k) clearance on 1997-01-27, under 510(k) number K963675.

Who is the listed applicant for THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE?

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

What is the FDA product code for THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE?

The FDA product code for THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE is KKX.

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 Micro-Medical Devices, Inc. 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.

K003695MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIESK983882MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400K951482ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)K951894ACCESS EXPANSION SYSTEMK945656THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPEK940141LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH

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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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