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FDA 510(k)

ELAN-E DISPOSALBE DRAPE

K-Number: K882494 · 1988-07-08

ApplicantDermacare Products, Inc.
Decision Date1988-07-08
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELAN-E DISPOSALBE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Dermacare Products, Inc.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K882494. 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 ELAN-E DISPOSALBE DRAPE?

ELAN-E DISPOSALBE DRAPE is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Dermacare Products, Inc.. The 510(k) number is K882494.

When did ELAN-E DISPOSALBE DRAPE receive FDA 510(k) clearance?

ELAN-E DISPOSALBE DRAPE received FDA 510(k) clearance on 1988-07-08, under 510(k) number K882494.

Who is the listed applicant for ELAN-E DISPOSALBE DRAPE?

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

What is the FDA product code for ELAN-E DISPOSALBE DRAPE?

The FDA product code for ELAN-E DISPOSALBE DRAPE is KKX.

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Other records listing Dermacare Products, 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.

K882421INFANT ELECTROSURGICAL DISPERSIVE ELECTRODEK871910SURGITEK DISPOSABLE BIPOLAR CORDK863279SURGI-TEK TUBE POSITIONERK863280DERMAMARKERK863278SURGI-WIPESK862367PRO-CLEAN

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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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