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FDA 510(k)

PMS DRAPE PACK

K-Number: K844465 · 1984-12-05

ApplicantProfessional Medical Services
Decision Date1984-12-05
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PMS DRAPE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Professional Medical Services. It received FDA 510(k) clearance on 1984-12-05 under 510(k) number K844465. 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 PMS DRAPE PACK?

PMS DRAPE PACK is a medical device that received FDA 510(k) clearance on 1984-12-05. The listed applicant is Professional Medical Services. The 510(k) number is K844465.

When did PMS DRAPE PACK receive FDA 510(k) clearance?

PMS DRAPE PACK received FDA 510(k) clearance on 1984-12-05, under 510(k) number K844465.

Who is the listed applicant for PMS DRAPE PACK?

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

What is the FDA product code for PMS DRAPE PACK?

The FDA product code for PMS DRAPE PACK is KKX.

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Other records listing Professional Medical Services 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.

K913094DISPOSABLE SLIDE VALVE MANIFOLDK910378PRESSURE MONITORING EXTENSION LINEK904508CONDOR ANALOG INFLATION SYRINGEK904954CONDOR DIGITAL INFLATION SYRINGEK902606RADIOPAQUE RULERK884577PROCEDURE READY TRAYS

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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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