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FDA 510(k)

DRAPE, SURGICAL

K-Number: K820078 · 1982-02-04

ApplicantJames L. Geraci & Associates, Inc.
Decision Date1982-02-04
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAPE, SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is James L. Geraci & Associates, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K820078. 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 DRAPE, SURGICAL?

DRAPE, SURGICAL is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is James L. Geraci & Associates, Inc.. The 510(k) number is K820078.

When did DRAPE, SURGICAL receive FDA 510(k) clearance?

DRAPE, SURGICAL received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820078.

Who is the listed applicant for DRAPE, SURGICAL?

The FDA 510(k) record lists James L. Geraci & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAPE, SURGICAL?

The FDA product code for DRAPE, SURGICAL is KKX.

Related Clinical Trials

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Other records listing James L. Geraci & Associates, 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.

K853927LASE SYSTEM IIK820091AIRMED SMOKE EVACUATION & FILTERK820079AIRMED PNEUMATIC EQUIP. FILTRA/CONTROLK811698CARL ZEISS INN MYRINGOTOMY TUBE LINE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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