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FDA 510(k)

STERILE BURNNET PRE-CUT (VARIOUS SIZES)

K-Number: K891459 · 1989-05-26

ApplicantWestern Medical, Ltd.
Decision Date1989-05-26
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE BURNNET PRE-CUT (VARIOUS SIZES) is the device name listed in this FDA 510(k) record. The listed applicant is Western Medical, Ltd.. It received FDA 510(k) clearance on 1989-05-26 under 510(k) number K891459. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE BURNNET PRE-CUT (VARIOUS SIZES)?

STERILE BURNNET PRE-CUT (VARIOUS SIZES) is a medical device that received FDA 510(k) clearance on 1989-05-26. The listed applicant is Western Medical, Ltd.. The 510(k) number is K891459.

When did STERILE BURNNET PRE-CUT (VARIOUS SIZES) receive FDA 510(k) clearance?

STERILE BURNNET PRE-CUT (VARIOUS SIZES) received FDA 510(k) clearance on 1989-05-26, under 510(k) number K891459.

Who is the listed applicant for STERILE BURNNET PRE-CUT (VARIOUS SIZES)?

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

What is the FDA product code for STERILE BURNNET PRE-CUT (VARIOUS SIZES)?

The FDA product code for STERILE BURNNET PRE-CUT (VARIOUS SIZES) is NAD.

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Other records listing Western Medical, Ltd. 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.

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Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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