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FDA 510(k)

ABSORBABLE GAUZE DRAPE

K-Number: K901465 · 1990-06-12

ApplicantUlti-Med Intl., Inc.
Decision Date1990-06-12
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ABSORBABLE GAUZE DRAPE is the device name listed in this FDA 510(k) record. The listed applicant is Ulti-Med Intl., Inc.. It received FDA 510(k) clearance on 1990-06-12 under 510(k) number K901465. 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 ABSORBABLE GAUZE DRAPE?

ABSORBABLE GAUZE DRAPE is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Ulti-Med Intl., Inc.. The 510(k) number is K901465.

When did ABSORBABLE GAUZE DRAPE receive FDA 510(k) clearance?

ABSORBABLE GAUZE DRAPE received FDA 510(k) clearance on 1990-06-12, under 510(k) number K901465.

Who is the listed applicant for ABSORBABLE GAUZE DRAPE?

The FDA 510(k) record lists Ulti-Med Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSORBABLE GAUZE DRAPE?

The FDA product code for ABSORBABLE GAUZE DRAPE is KKX.

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Other records listing Ulti-Med Intl., Inc. 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.

K103011ULTICARE SAFETY INSULIN SYRINGEK923176SURGICAL INSTRUMENT KIT, DISPOSABLEK923175SURGICAL INSTRUMENT KIT, DISPOSABLEK920989SURGICAL INSTRUMENT KIT, DISPOSABLEK922828ULCER WOUND TRAYK914244STERILE CUSTOM SURGICAL KITS

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Related Devices (Code: KKX)

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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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