ULTRATINE FOREHEAD

Screw, Fixation, Bone

COAPT SYSTEMS, INC.

The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Ultratine Forehead.

Pre-market Notification Details

Device IDK060249
510k NumberK060249
Device Name:ULTRATINE FOREHEAD
ClassificationScrew, Fixation, Bone
Applicant COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto,  CA  94303
ContactLinda Ruedy
CorrespondentLinda Ruedy
COAPT SYSTEMS, INC. 1820 EMBARCADERO RD. Palo Alto,  CA  94303
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-31
Decision Date2006-06-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847399006882 K060249 000
00847399006875 K060249 000

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