FDA 510(k)

TOWELS

K-Number: K864528 · 1986-12-18

Decision Date1986-12-18

Product Code

DecisionSubstantially Equivalent

Device Summary

TOWELS is the device name listed in this FDA 510(k) record. The listed applicant is Elof Hansson, Inc.. It received FDA 510(k) clearance on 1986-12-18 under 510(k) number K864528. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOWELS?

TOWELS is a medical device that received FDA 510(k) clearance on 1986-12-18. The listed applicant is Elof Hansson, Inc.. The 510(k) number is K864528.

When did TOWELS receive FDA 510(k) clearance?

TOWELS received FDA 510(k) clearance on 1986-12-18, under 510(k) number K864528.

Who is the listed applicant for TOWELS?

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

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Elof Hansson, Inc. as applicant

K864529LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.