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FDA 510(k)

SURGICAL BANDAGES/SUNLEEP DX

K-Number: K801840 · 1980-09-09

ApplicantMartin'S Maine Exchange
Decision Date1980-09-09
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL BANDAGES/SUNLEEP DX is the device name listed in this FDA 510(k) record. The listed applicant is Martin'S Maine Exchange. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801840. 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 SURGICAL BANDAGES/SUNLEEP DX?

SURGICAL BANDAGES/SUNLEEP DX is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Martin'S Maine Exchange. The 510(k) number is K801840.

When did SURGICAL BANDAGES/SUNLEEP DX receive FDA 510(k) clearance?

SURGICAL BANDAGES/SUNLEEP DX received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801840.

Who is the listed applicant for SURGICAL BANDAGES/SUNLEEP DX?

The FDA 510(k) record lists Martin'S Maine Exchange as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL BANDAGES/SUNLEEP DX?

The FDA product code for SURGICAL BANDAGES/SUNLEEP DX 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 Martin'S Maine Exchange 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.

K810008ALP-KIIK801837PLASTIC STRIP BANDAGESK801839DISPOSABLE HYPODERMIC NEEDLES

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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