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FDA 510(k)

SILASTIC VOICE PROSTHESIS

K-Number: K812864 · 1981-11-24

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1981-11-24
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILASTIC VOICE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K812864. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILASTIC VOICE PROSTHESIS?

SILASTIC VOICE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K812864.

When did SILASTIC VOICE PROSTHESIS receive FDA 510(k) clearance?

SILASTIC VOICE PROSTHESIS received FDA 510(k) clearance on 1981-11-24, under 510(k) number K812864.

Who is the listed applicant for SILASTIC VOICE PROSTHESIS?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILASTIC VOICE PROSTHESIS?

The FDA product code for SILASTIC VOICE PROSTHESIS is EWL.

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Other records listing Dow Corning Corp. Healthcare Industries Materials as applicant

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Related Devices (Code: EWL)

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.

K240763FirstFit Surgical KitFreudenberg Medical, LLCK131947PROVOX VEGA PUNCTURE SETAtos Medical ABK092593PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical ABK093258BLOM-SINGER INDWELLING TEP OCCLUDERHelix Medical, LLCK090455PROVOX VEGA, MODEL 8130-8135Atos Medical ABK082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESHelix Medical, LLC

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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