FDA 510(k)

THE KLINE APPLICATOR

K-Number: K823517 · 1983-01-18

Decision Date1983-01-18

Product CodeHGD

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

THE KLINE APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kline Technologies, Ltd.. It received FDA 510(k) clearance on 1983-01-18 under 510(k) number K823517. The device is classified under product code HGD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE KLINE APPLICATOR?

THE KLINE APPLICATOR is a medical device that received FDA 510(k) clearance on 1983-01-18. The listed applicant is Kline Technologies, Ltd.. The 510(k) number is K823517.

When did THE KLINE APPLICATOR receive FDA 510(k) clearance?

THE KLINE APPLICATOR received FDA 510(k) clearance on 1983-01-18, under 510(k) number K823517.

Who is the listed applicant for THE KLINE APPLICATOR?

The FDA 510(k) record lists Kline Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE KLINE APPLICATOR?

The FDA product code for THE KLINE APPLICATOR is HGD.

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

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.