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FDA 510(k)

STERILE SURGICAL GOWN PACK

K-Number: K911131 · 1991-09-16

ApplicantCentral Georgia Ancillary Health Systems
Decision Date1991-09-16
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SURGICAL GOWN PACK is the device name listed in this FDA 510(k) record. The listed applicant is Central Georgia Ancillary Health Systems. It received FDA 510(k) clearance on 1991-09-16 under 510(k) number K911131. 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 STERILE SURGICAL GOWN PACK?

STERILE SURGICAL GOWN PACK is a medical device that received FDA 510(k) clearance on 1991-09-16. The listed applicant is Central Georgia Ancillary Health Systems. The 510(k) number is K911131.

When did STERILE SURGICAL GOWN PACK receive FDA 510(k) clearance?

STERILE SURGICAL GOWN PACK received FDA 510(k) clearance on 1991-09-16, under 510(k) number K911131.

Who is the listed applicant for STERILE SURGICAL GOWN PACK?

The FDA 510(k) record lists Central Georgia Ancillary Health Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE SURGICAL GOWN PACK?

The FDA product code for STERILE SURGICAL GOWN PACK is KKX.

Related Clinical Trials

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.

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Other records listing Central Georgia Ancillary Health Systems 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.

K923798SURGICAL GOWN PACKK911132MULTIPLE, SURGICAL DRAPE PACK

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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