REPLAM HYDROXYAPATITE

Bone Grafting Material, Synthetic

REPLAM CORP.

The following data is part of a premarket notification filed by Replam Corp. with the FDA for Replam Hydroxyapatite.

Pre-market Notification Details

Device IDK830304
510k NumberK830304
Device Name:REPLAM HYDROXYAPATITE
ClassificationBone Grafting Material, Synthetic
Applicant REPLAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-28
Decision Date1983-04-06

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