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)

ORAL PROCEDURE PACK

K-Number: K950743 · 1995-03-31

ApplicantTransidyne General Corp.
Decision Date1995-03-31
Product CodeEGS
Advisory CommitteeDE
DecisionUnknown

Device Summary

ORAL PROCEDURE PACK is the device name listed in this FDA 510(k) record. The listed applicant is Transidyne General Corp.. It received FDA 510(k) clearance on 1995-03-31 under 510(k) number K950743. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ORAL PROCEDURE PACK?

ORAL PROCEDURE PACK is a medical device that received FDA 510(k) clearance on 1995-03-31. The listed applicant is Transidyne General Corp.. The 510(k) number is K950743.

When did ORAL PROCEDURE PACK receive FDA 510(k) clearance?

ORAL PROCEDURE PACK received FDA 510(k) clearance on 1995-03-31, under 510(k) number K950743.

Who is the listed applicant for ORAL PROCEDURE PACK?

The FDA 510(k) record lists Transidyne General Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL PROCEDURE PACK?

The FDA product code for ORAL PROCEDURE PACK is EGS.

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 Transidyne General Corp. 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.

K961217BODILY FLUID DISPOSAL KITK955658LACERATION TRAYK950773PROPHYLAXIS PACKK950449SURGICAL BURK950403SURGICAL SAW BLADESK924811I.V. START KIT

View all 21 devices →

Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

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.

↑