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FDA 510(k)

SPUNGARD & SURG. DRAPES-GOWNS & PACKS

K-Number: K842115 · 1984-06-11

ApplicantKimberly-Clark Corp.
Decision Date1984-06-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPUNGARD & SURG. DRAPES-GOWNS & PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corp.. It received FDA 510(k) clearance on 1984-06-11 under 510(k) number K842115. 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 SPUNGARD & SURG. DRAPES-GOWNS & PACKS?

SPUNGARD & SURG. DRAPES-GOWNS & PACKS is a medical device that received FDA 510(k) clearance on 1984-06-11. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K842115.

When did SPUNGARD & SURG. DRAPES-GOWNS & PACKS receive FDA 510(k) clearance?

SPUNGARD & SURG. DRAPES-GOWNS & PACKS received FDA 510(k) clearance on 1984-06-11, under 510(k) number K842115.

Who is the listed applicant for SPUNGARD & SURG. DRAPES-GOWNS & PACKS?

The FDA 510(k) record lists Kimberly-Clark Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPUNGARD & SURG. DRAPES-GOWNS & PACKS?

The FDA product code for SPUNGARD & SURG. DRAPES-GOWNS & PACKS is KKX.

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Other records listing Kimberly-Clark Corp. as applicant

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K131879KC 300 SURGICAL MASKK131841KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVEK131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBEK120985KIMVENT MICROCUFF SUBGLOTTIC SUCTIONINGK112805KIMGUARD ONE-STEP STERILIZATION WRAPK113423KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

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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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