RICHARDS PORP

Prosthesis, Partial Ossicular Replacement

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Richards Porp.

Pre-market Notification Details

Device IDK952481
510k NumberK952481
Device Name:RICHARDS PORP
ClassificationProsthesis, Partial Ossicular Replacement
Applicant SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett,  TN  38133
ContactRonald K Smith
CorrespondentRonald K Smith
SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett,  TN  38133
Product CodeETB  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-30
Decision Date1995-06-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925024465 K952481 000
00821925022386 K952481 000

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