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FDA 510(k)

SAFE-T-CAP NEEDLE COVER

K-Number: K896219 · 1990-01-22

ApplicantAusmedics Pty , Ltd.
Decision Date1990-01-22
Product CodeDZM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAFE-T-CAP NEEDLE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Ausmedics Pty , Ltd.. It received FDA 510(k) clearance on 1990-01-22 under 510(k) number K896219. The device is classified under product code DZM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE-T-CAP NEEDLE COVER?

SAFE-T-CAP NEEDLE COVER is a medical device that received FDA 510(k) clearance on 1990-01-22. The listed applicant is Ausmedics Pty , Ltd.. The 510(k) number is K896219.

When did SAFE-T-CAP NEEDLE COVER receive FDA 510(k) clearance?

SAFE-T-CAP NEEDLE COVER received FDA 510(k) clearance on 1990-01-22, under 510(k) number K896219.

Who is the listed applicant for SAFE-T-CAP NEEDLE COVER?

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

What is the FDA product code for SAFE-T-CAP NEEDLE COVER?

The FDA product code for SAFE-T-CAP NEEDLE COVER is DZM.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ausmedics Pty , Ltd. 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.

K895432SAFE-T-CAP

Related Devices (Code: DZM)

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.

K990511X-TIP INTRAOSSEOUS PERFORATORSchiff & Co.K920758JENKER NEEDLE STICK PROTECTORDentsply Intl.K914562ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEMAseptic Dental Technologies, Inc.K913573SAFETY PLUS DENTAL INJECTION NEEDLESpecialites SeptodontK910475DENTAL NEEDLE PROTECTIVE SYSTEMHealth Technology Systems, Inc.K910446STABIDENT LOCAL ANESTHESIA SYSTEMFairfax Dental, Inc.

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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