ACE OPEN-BACK HALO RING

Component, Traction, Invasive

ACE MEDICAL CO.

The following data is part of a premarket notification filed by Ace Medical Co. with the FDA for Ace Open-back Halo Ring.

Pre-market Notification Details

Device IDK914858
510k NumberK914858
Device Name:ACE OPEN-BACK HALO RING
ClassificationComponent, Traction, Invasive
Applicant ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles,  CA  90061
ContactClaude O Pering
CorrespondentClaude O Pering
ACE MEDICAL CO. 14105 SOUTH AVALON BLVD. Los Angeles,  CA  90061
Product CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-29
Decision Date1991-11-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.