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FDA 510(k)

ASPEN ESMARK BANDAGE

K-Number: K872868 · 1987-07-31

ApplicantAspen Laboratories, Inc.
Decision Date1987-07-31
Product CodeFQM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASPEN ESMARK BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-31 under 510(k) number K872868. The device is classified under product code FQM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPEN ESMARK BANDAGE?

ASPEN ESMARK BANDAGE is a medical device that received FDA 510(k) clearance on 1987-07-31. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K872868.

When did ASPEN ESMARK BANDAGE receive FDA 510(k) clearance?

ASPEN ESMARK BANDAGE received FDA 510(k) clearance on 1987-07-31, under 510(k) number K872868.

Who is the listed applicant for ASPEN ESMARK BANDAGE?

The FDA 510(k) record lists Aspen Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASPEN ESMARK BANDAGE?

The FDA product code for ASPEN ESMARK BANDAGE is FQM.

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Other records listing Aspen Laboratories, Inc. as applicant

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Related Devices (Code: FQM)

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.

K040936PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDELeda Co., Ltd.K040054BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLETheodore BarashK013244COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBEMed Gen, Inc.K952738SKIN SAVER SYSTEMSSkin Saver Systems, Inc.K840107TUBE-BANDAGE FOR HUMAN DIGITS 200Zens Health Care ProductsK831728MEDICALEXMedicalex

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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