SCHURING OSSICLE CUP & COLUMELLA PROSTH.

Prosthesis, Partial Ossicular Replacement

RICHARD'S MEDICAL EQUIP., INC.

The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Schuring Ossicle Cup & Columella Prosth..

Pre-market Notification Details

Device IDK802431
510k NumberK802431
Device Name:SCHURING OSSICLE CUP & COLUMELLA PROSTH.
ClassificationProsthesis, Partial Ossicular Replacement
Applicant RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeETB  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-06
Decision Date1980-11-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925020627 K802431 000
00821925014312 K802431 000
00821925014350 K802431 000
00821925014961 K802431 000
00821925014978 K802431 000
00821925014985 K802431 000
00821925014992 K802431 000
00821925015005 K802431 000
00821925015302 K802431 000
00821925015319 K802431 000
00821925015326 K802431 000
00821925017733 K802431 000
00821925020610 K802431 000
00821925014077 K802431 000

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