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)

GELATO PROPHYLAXIS PASTE

K-Number: K042048 · 2004-10-26

ApplicantDeepak Products, Inc.
Decision Date2004-10-26
Product CodeEJR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GELATO PROPHYLAXIS PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Deepak Products, Inc.. It received FDA 510(k) clearance on 2004-10-26 under 510(k) number K042048. The device is classified under product code EJR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELATO PROPHYLAXIS PASTE?

GELATO PROPHYLAXIS PASTE is a medical device that received FDA 510(k) clearance on 2004-10-26. The listed applicant is Deepak Products, Inc.. The 510(k) number is K042048.

When did GELATO PROPHYLAXIS PASTE receive FDA 510(k) clearance?

GELATO PROPHYLAXIS PASTE received FDA 510(k) clearance on 2004-10-26, under 510(k) number K042048.

Who is the listed applicant for GELATO PROPHYLAXIS PASTE?

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

What is the FDA product code for GELATO PROPHYLAXIS PASTE?

The FDA product code for GELATO PROPHYLAXIS PASTE is EJR.

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: EJR)

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.

K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.AK121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.K103114OSSPRAY SYLC CROsspray, Ltd.K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.K101104REMIN PROVoco GmbHK100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, 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.

↑