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FDA 510(k)

THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE

K-Number: K945656 · 1995-03-28

ApplicantMicro-Medical Devices, Inc.
Decision Date1995-03-28
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE COUPLER/DRAPE(TM), VIDEO CAMERA 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 1995-03-28 under 510(k) number K945656. 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 COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE?

THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE is a medical device that received FDA 510(k) clearance on 1995-03-28. The listed applicant is Micro-Medical Devices, Inc.. The 510(k) number is K945656.

When did THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE receive FDA 510(k) clearance?

THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE received FDA 510(k) clearance on 1995-03-28, under 510(k) number K945656.

Who is the listed applicant for THE COUPLER/DRAPE(TM), VIDEO CAMERA 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 COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE?

The FDA product code for THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE is KKX.

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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-1400K963675THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPEK951482ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)K951894ACCESS EXPANSION SYSTEMK940141LAPARAOSCOPES 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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