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)

DENTAL COTTON ROLLS

K-Number: K841327 · 1984-07-03

ApplicantIntl. Verbandstoff-Fabrik Schaffhau
Decision Date1984-07-03
Product CodeEFN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL COTTON ROLLS is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Verbandstoff-Fabrik Schaffhau. It received FDA 510(k) clearance on 1984-07-03 under 510(k) number K841327. The device is classified under product code EFN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL COTTON ROLLS?

DENTAL COTTON ROLLS is a medical device that received FDA 510(k) clearance on 1984-07-03. The listed applicant is Intl. Verbandstoff-Fabrik Schaffhau. The 510(k) number is K841327.

When did DENTAL COTTON ROLLS receive FDA 510(k) clearance?

DENTAL COTTON ROLLS received FDA 510(k) clearance on 1984-07-03, under 510(k) number K841327.

Who is the listed applicant for DENTAL COTTON ROLLS?

The FDA 510(k) record lists Intl. Verbandstoff-Fabrik Schaffhau as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL COTTON ROLLS?

The FDA product code for DENTAL COTTON ROLLS is EFN.

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 Intl. Verbandstoff-Fabrik Schaffhau 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.

K861338DENTAL COTTON ROLLS, STERILE AND NON-STERILE

Related Devices (Code: EFN)

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.

K872810STRUNG DENTAL ROLLSAmerican Silk Sutures, Inc.K871464MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STERMedgroup Enterprises, Inc.K863764COTTON ROLLS, NON-STERILEThe Medical Group, Inc.K861338DENTAL COTTON ROLLS, STERILE AND NON-STERILEIntl. Verbandstoff-Fabrik SchaffhauK861727COTTON FILLED GAUZE SPONGES 2 X 2Cross Country Paper Products Corp.K843539TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-Molnlycke A/S Hospital Products

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.

↑