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FDA 510(k)

ACE COLD BANDAGE

K-Number: K810402 · 1981-03-04

Decision Date1981-03-04
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ACE COLD BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1981-03-04 under 510(k) number K810402. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE COLD BANDAGE?

ACE COLD BANDAGE is a medical device that received FDA 510(k) clearance on 1981-03-04. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K810402.

When did ACE COLD BANDAGE receive FDA 510(k) clearance?

ACE COLD BANDAGE received FDA 510(k) clearance on 1981-03-04, under 510(k) number K810402.

Who is the listed applicant for ACE COLD BANDAGE?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE COLD BANDAGE?

The FDA product code for ACE COLD BANDAGE is IME.

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.

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic 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.

View all 632 devices →

Related Devices (Code: IME)

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.

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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