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FDA 510(k)

SURG-O-PAK PREP PAD

K-Number: K781534 · 1978-10-24

ApplicantConvertors
Decision Date1978-10-24
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURG-O-PAK PREP PAD is the device name listed in this FDA 510(k) record. The listed applicant is Convertors. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781534. 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 PREP PAD?

SURG-O-PAK PREP PAD is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Convertors. The 510(k) number is K781534.

When did SURG-O-PAK PREP PAD receive FDA 510(k) clearance?

SURG-O-PAK PREP PAD received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781534.

Who is the listed applicant for SURG-O-PAK PREP PAD?

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 PREP PAD?

The FDA product code for SURG-O-PAK PREP PAD is KKX.

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.

K780627SURG-O-PAK, GOWNS, SHEETS, AND TOWELSK790234DRAPE PACKS, SURGICAL GOWNSK781959SURGICAL GOWNS, SHEETSK781099SURGICAL 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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