SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT

Prosthesis, Chin, Internal

SPECTRUM DESIGNS, INC.

The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Concave Back Chin Implant.

Pre-market Notification Details

Device IDK980445
510k NumberK980445
Device Name:SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
ClassificationProsthesis, Chin, Internal
Applicant SPECTRUM DESIGNS, INC. 5921 C. MATTHEWS ST. Goleta,  CA  93117
ContactJim Dishman
CorrespondentJim Dishman
SPECTRUM DESIGNS, INC. 5921 C. MATTHEWS ST. Goleta,  CA  93117
Product CodeFWP  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-05
Decision Date1998-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724250944S1 K980445 000
M724250934S1 K980445 000
M724250924S1 K980445 000
M724250914S1 K980445 000
M7249000061 K980445 000

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