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FDA 510(k)

TRIANGLE BANDAGE STERILE

K-Number: K831283 · 1983-08-12

ApplicantPac-Kit Safety Equipment Co.
Decision Date1983-08-12
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIANGLE BANDAGE STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Kit Safety Equipment Co.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831283. 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 TRIANGLE BANDAGE STERILE?

TRIANGLE BANDAGE STERILE is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Pac-Kit Safety Equipment Co.. The 510(k) number is K831283.

When did TRIANGLE BANDAGE STERILE receive FDA 510(k) clearance?

TRIANGLE BANDAGE STERILE received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831283.

Who is the listed applicant for TRIANGLE BANDAGE STERILE?

The FDA 510(k) record lists Pac-Kit Safety Equipment Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIANGLE BANDAGE STERILE?

The FDA product code for TRIANGLE BANDAGE STERILE is NAD.

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 Pac-Kit Safety Equipment 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.

K831282BANDAGE COMPRESSK831284GAUZE BANDAGEK831281GAUZE COMPRESS

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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