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FDA 510(k)

REDI-DRAPE

K-Number: K830723 · 1983-04-12

ApplicantThe Oec Group
Decision Date1983-04-12
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REDI-DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is The Oec Group. It received FDA 510(k) clearance on 1983-04-12 under 510(k) number K830723. 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 REDI-DRAPE?

REDI-DRAPE is a medical device that received FDA 510(k) clearance on 1983-04-12. The listed applicant is The Oec Group. The 510(k) number is K830723.

When did REDI-DRAPE receive FDA 510(k) clearance?

REDI-DRAPE received FDA 510(k) clearance on 1983-04-12, under 510(k) number K830723.

Who is the listed applicant for REDI-DRAPE?

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

What is the FDA product code for REDI-DRAPE?

The FDA product code for REDI-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 The Oec Group 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.

K831420HIP PROSTHESIS -VARIOUSK811656POWERED WHEELCHAIR

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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