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FDA 510(k)

BLAISE-RATHAEL VOICE PROSTHESIS

K-Number: K832852 · 1983-09-29

ApplicantRichards Medical Co., Inc.
Decision Date1983-09-29
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BLAISE-RATHAEL VOICE PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832852. 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 BLAISE-RATHAEL VOICE PROSTHESIS?

BLAISE-RATHAEL VOICE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K832852.

When did BLAISE-RATHAEL VOICE PROSTHESIS receive FDA 510(k) clearance?

BLAISE-RATHAEL VOICE PROSTHESIS received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832852.

Who is the listed applicant for BLAISE-RATHAEL VOICE PROSTHESIS?

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

What is the FDA product code for BLAISE-RATHAEL VOICE PROSTHESIS?

The FDA product code for BLAISE-RATHAEL VOICE PROSTHESIS is EWL.

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Other records listing Richards Medical Co., Inc. 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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