INCUS PROSTHESIS

Prosthesis, Partial Ossicular Replacement

RICHARDS MEDICAL CO., INC.

The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Incus Prosthesis.

Pre-market Notification Details

Device IDK844961
510k NumberK844961
Device Name:INCUS PROSTHESIS
ClassificationProsthesis, Partial Ossicular Replacement
Applicant RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactRobert F Games
CorrespondentRobert F Games
RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeETB  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-21
Decision Date1985-02-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925040960 K844961 000
00821925014732 K844961 000
00821925015524 K844961 000
00821925017689 K844961 000
00821925017696 K844961 000
00821925017702 K844961 000
00821925017719 K844961 000
00821925017726 K844961 000
00821925017900 K844961 000
00821925017917 K844961 000
00821925012219 K844961 000

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