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)

NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE

K-Number: K955657 · 1996-03-12

ApplicantNorth State Plastics, Inc.
Decision Date1996-03-12
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is North State Plastics, Inc.. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K955657. The device is classified under product code BYP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE?

NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is North State Plastics, Inc.. The 510(k) number is K955657.

When did NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE receive FDA 510(k) clearance?

NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE received FDA 510(k) clearance on 1996-03-12, under 510(k) number K955657.

Who is the listed applicant for NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE?

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

What is the FDA product code for NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE?

The FDA product code for NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE is BYP.

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 North State Plastics, Inc. 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.

K955656NORTH STATE PLASTICS AEROSOL TEE

Related Devices (Code: BYP)

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.

K944512TRUZONE PFM DISPOSABLE MOUTHPIECEMonaghan Medical Corp.K893791BREATHING MOUTHPIECEDiemolding Corp.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, Inc.K862788MP-4400 MOUTHPIECE-FLANGE SEALMedipart Jerry Alexander

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.

↑