ACE RECONSTRUCTIVE PLATE

Plate, Fixation, Bone

ACE MEDICAL CO.

The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Reconstructive Plate.

Pre-market Notification Details

Device IDK905595
510k NumberK905595
Device Name:ACE RECONSTRUCTIVE PLATE
ClassificationPlate, Fixation, Bone
Applicant ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles,  CA  90061
ContactGloria Teske
CorrespondentGloria Teske
ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles,  CA  90061
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-13
Decision Date1991-03-14

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