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FDA 510(k)

BOUNDARY SURGICAL DRAPES WITH ADHESIVE

K-Number: K802652 · 1980-11-12

ApplicantProcter & Gamble Mfg. Co.
Decision Date1980-11-12
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BOUNDARY SURGICAL DRAPES WITH ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Procter & Gamble Mfg. Co.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802652. 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 BOUNDARY SURGICAL DRAPES WITH ADHESIVE?

BOUNDARY SURGICAL DRAPES WITH ADHESIVE is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Procter & Gamble Mfg. Co.. The 510(k) number is K802652.

When did BOUNDARY SURGICAL DRAPES WITH ADHESIVE receive FDA 510(k) clearance?

BOUNDARY SURGICAL DRAPES WITH ADHESIVE received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802652.

Who is the listed applicant for BOUNDARY SURGICAL DRAPES WITH ADHESIVE?

The FDA 510(k) record lists Procter & Gamble Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOUNDARY SURGICAL DRAPES WITH ADHESIVE?

The FDA product code for BOUNDARY SURGICAL DRAPES WITH ADHESIVE is KKX.

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Other records listing Procter & Gamble Mfg. Co. 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.

K873457SCENTED OR SCENTED DEODORIZED MENSTRUAL PADSK873036ATTENDS INCONTINENT BRIEFK864673UNSCENTED MENSTRUAL PADK861863MODIFIED PROTECTIVE GARMENTK862348SINGLE-USE PATIENT UNDERPADK860598MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS

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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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