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FDA 510(k)

SILICONE PUTTY EAR PLUGS

K-Number: K971517 · 1997-06-02

ApplicantBentec Medical, Inc.
Decision Date1997-06-02
Product CodeEWD
DecisionSubstantially Equivalent

Device Summary

SILICONE PUTTY EAR PLUGS is the device name listed in this FDA 510(k) record. The listed applicant is Bentec Medical, Inc.. It received FDA 510(k) clearance on 1997-06-02 under 510(k) number K971517. The device is classified under product code EWD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE PUTTY EAR PLUGS?

SILICONE PUTTY EAR PLUGS is a medical device that received FDA 510(k) clearance on 1997-06-02. The listed applicant is Bentec Medical, Inc.. The 510(k) number is K971517.

When did SILICONE PUTTY EAR PLUGS receive FDA 510(k) clearance?

SILICONE PUTTY EAR PLUGS received FDA 510(k) clearance on 1997-06-02, under 510(k) number K971517.

Who is the listed applicant for SILICONE PUTTY EAR PLUGS?

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

What is the FDA product code for SILICONE PUTTY EAR PLUGS?

The FDA product code for SILICONE PUTTY EAR PLUGS 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.

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Other records listing Bentec Medical, 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.

K002650VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726K971411DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K

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.K962292HEARSAVEREmtech LaboratoriesK960500THE VIRTUAL M-332Virtual Corp.K945376DOC'S PROPLUGS EAR PLUGSDoc'S Proplugs, Inc.K930203MODEL 322 CLINICAL AUDIOMETERVirtual Corp.

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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