PEDIATRIC PRC

Orthosis, Spondylolisthesis Spinal Fixation

ACROMED CORP.

The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Pediatric Prc.

Pre-market Notification Details

Device IDK981113
510k NumberK981113
Device Name:PEDIATRIC PRC
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant ACROMED CORP. 3303 CARNEGIE AVE. Cleveland,  OH  44115
ContactWilliam Christianson
CorrespondentWilliam Christianson
ACROMED CORP. 3303 CARNEGIE AVE. Cleveland,  OH  44115
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-27
Decision Date1998-05-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034243108 K981113 000

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