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FDA 510(k)

SEAL-RITE SILICONE EAR PLUG

K-Number: K910177 · 1991-06-24

ApplicantFlents Products Co., Inc.
Decision Date1991-06-24
Product CodeEWD
DecisionSubstantially Equivalent

Device Summary

SEAL-RITE SILICONE EAR PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Flents Products Co., Inc.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K910177. The device is classified under product code EWD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEAL-RITE SILICONE EAR PLUG?

SEAL-RITE SILICONE EAR PLUG is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Flents Products Co., Inc.. The 510(k) number is K910177.

When did SEAL-RITE SILICONE EAR PLUG receive FDA 510(k) clearance?

SEAL-RITE SILICONE EAR PLUG received FDA 510(k) clearance on 1991-06-24, under 510(k) number K910177.

Who is the listed applicant for SEAL-RITE SILICONE EAR PLUG?

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

What is the FDA product code for SEAL-RITE SILICONE EAR PLUG?

The FDA product code for SEAL-RITE SILICONE EAR PLUG is EWD.

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 Flents Products Co., 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.

K915739#903 SILAFLEX II

Related Devices (Code: EWD)

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.

K020296ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057Apothecary Products, Inc.K972923SUPER SILIPLUGS EAR PLUGSInterview Medical Technology Corp.K971517SILICONE PUTTY EAR PLUGSBentec Medical, Inc.K962292HEARSAVEREmtech LaboratoriesK960500THE VIRTUAL M-332Virtual Corp.K945376DOC'S PROPLUGS EAR PLUGSDoc'S Proplugs, 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.

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