Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MONTROSE DRESSING APPLICATORS

K-Number: K905519 · 1991-03-06

ApplicantOlemunda Pty , Ltd.
Decision Date1991-03-06
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONTROSE DRESSING APPLICATORS is the device name listed in this FDA 510(k) record. The listed applicant is Olemunda Pty , Ltd.. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K905519. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONTROSE DRESSING APPLICATORS?

MONTROSE DRESSING APPLICATORS is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is Olemunda Pty , Ltd.. The 510(k) number is K905519.

When did MONTROSE DRESSING APPLICATORS receive FDA 510(k) clearance?

MONTROSE DRESSING APPLICATORS received FDA 510(k) clearance on 1991-03-06, under 510(k) number K905519.

Who is the listed applicant for MONTROSE DRESSING APPLICATORS?

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

What is the FDA product code for MONTROSE DRESSING APPLICATORS?

The FDA product code for MONTROSE DRESSING APPLICATORS is NAD.

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

Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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.

↑