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)

PNEUMATIC POWERED BUR

K-Number: K780139 · 1978-02-01

ApplicantNorth Palm Beach Orthodepic Assoc.
Decision Date1978-02-01
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PNEUMATIC POWERED BUR is the device name listed in this FDA 510(k) record. The listed applicant is North Palm Beach Orthodepic Assoc.. It received FDA 510(k) clearance on 1978-02-01 under 510(k) number K780139. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMATIC POWERED BUR?

PNEUMATIC POWERED BUR is a medical device that received FDA 510(k) clearance on 1978-02-01. The listed applicant is North Palm Beach Orthodepic Assoc.. The 510(k) number is K780139.

When did PNEUMATIC POWERED BUR receive FDA 510(k) clearance?

PNEUMATIC POWERED BUR received FDA 510(k) clearance on 1978-02-01, under 510(k) number K780139.

Who is the listed applicant for PNEUMATIC POWERED BUR?

The FDA 510(k) record lists North Palm Beach Orthodepic Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PNEUMATIC POWERED BUR?

The FDA product code for PNEUMATIC POWERED BUR is HSZ.

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: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, 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.

↑