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FDA 510(k)

SURG. GOWN & DRAPE, LOW LINT TREATMENT

K-Number: K781019 · 1978-08-14

ApplicantKimberly-Clark Corp.
Decision Date1978-08-14
Product CodeKKY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURG. GOWN & DRAPE, LOW LINT TREATMENT 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 1978-08-14 under 510(k) number K781019. The device is classified under product code KKY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURG. GOWN & DRAPE, LOW LINT TREATMENT?

SURG. GOWN & DRAPE, LOW LINT TREATMENT is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Kimberly-Clark Corp.. The 510(k) number is K781019.

When did SURG. GOWN & DRAPE, LOW LINT TREATMENT receive FDA 510(k) clearance?

SURG. GOWN & DRAPE, LOW LINT TREATMENT received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781019.

Who is the listed applicant for SURG. GOWN & DRAPE, LOW LINT TREATMENT?

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 SURG. GOWN & DRAPE, LOW LINT TREATMENT?

The FDA product code for SURG. GOWN & DRAPE, LOW LINT TREATMENT is KKY.

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Other records listing Kimberly-Clark Corp. as applicant

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Related Devices (Code: KKY)

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.

K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLCK161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.K160988Biopor, AOC Porous Polyethylene, CereporCeremed , Inc.K123908OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USAK111323SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTSSynthes, Inc.K103010STRYKER PATIENT SPECIFIC POLYMER IMPLANTHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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