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FDA 510(k)

#903 SILAFLEX II

K-Number: K915739 · 1992-06-30

ApplicantFlents Products Co., Inc.
Decision Date1992-06-30
Product CodeEWD
DecisionSubstantially Equivalent

Device Summary

#903 SILAFLEX II 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 1992-06-30 under 510(k) number K915739. The device is classified under product code EWD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the #903 SILAFLEX II?

#903 SILAFLEX II is a medical device that received FDA 510(k) clearance on 1992-06-30. The listed applicant is Flents Products Co., Inc.. The 510(k) number is K915739.

When did #903 SILAFLEX II receive FDA 510(k) clearance?

#903 SILAFLEX II received FDA 510(k) clearance on 1992-06-30, under 510(k) number K915739.

Who is the listed applicant for #903 SILAFLEX II?

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 #903 SILAFLEX II?

The FDA product code for #903 SILAFLEX II 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 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.

K910177SEAL-RITE SILICONE EAR PLUG

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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