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FDA 510(k)

ORS-111

K-Number: K953654 · 1995-09-22

ApplicantO.R. Solutions, Inc.
Decision Date1995-09-22
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORS-111 is the device name listed in this FDA 510(k) record. The listed applicant is O.R. Solutions, Inc.. It received FDA 510(k) clearance on 1995-09-22 under 510(k) number K953654. 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 ORS-111?

ORS-111 is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is O.R. Solutions, Inc.. The 510(k) number is K953654.

When did ORS-111 receive FDA 510(k) clearance?

ORS-111 received FDA 510(k) clearance on 1995-09-22, under 510(k) number K953654.

Who is the listed applicant for ORS-111?

The FDA 510(k) record lists O.R. Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORS-111?

The FDA product code for ORS-111 is KKX.

Other records listing O.R. Solutions, 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.

K051979ORS MODEL 6000 ENDOSCOPE HOLDERK0232831075LD HUSH-SLUSHK023282ORS-3000LDK021288ORS-1000LDK021289WARMER 2000LDK960836DMS-9000

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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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