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FDA 510(k)

SURG-O-PAK, GOWNS, SHEETS, AND TOWELS

K-Number: K780627 · 1979-07-11

ApplicantConvertors
Decision Date1979-07-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURG-O-PAK, GOWNS, SHEETS, AND TOWELS is the device name listed in this FDA 510(k) record. The listed applicant is Convertors. It received FDA 510(k) clearance on 1979-07-11 under 510(k) number K780627. 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 SURG-O-PAK, GOWNS, SHEETS, AND TOWELS?

SURG-O-PAK, GOWNS, SHEETS, AND TOWELS is a medical device that received FDA 510(k) clearance on 1979-07-11. The listed applicant is Convertors. The 510(k) number is K780627.

When did SURG-O-PAK, GOWNS, SHEETS, AND TOWELS receive FDA 510(k) clearance?

SURG-O-PAK, GOWNS, SHEETS, AND TOWELS received FDA 510(k) clearance on 1979-07-11, under 510(k) number K780627.

Who is the listed applicant for SURG-O-PAK, GOWNS, SHEETS, AND TOWELS?

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

What is the FDA product code for SURG-O-PAK, GOWNS, SHEETS, AND TOWELS?

The FDA product code for SURG-O-PAK, GOWNS, SHEETS, AND TOWELS is KKX.

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Other records listing Convertors 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.

K790234DRAPE PACKS, SURGICAL GOWNSK781959SURGICAL GOWNS, SHEETSK781534SURG-O-PAK PREP PADK781099SURGICAL GOWNS AND DRAPESK780169MASK, SURGICALK771929PEDIATRICS GOWN

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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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