REPLAM HYDROXYAPATATITE

Syringe, Piston

REPLAM CORP.

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

Pre-market Notification Details

Device IDK822420
510k NumberK822420
Device Name:REPLAM HYDROXYAPATATITE
ClassificationSyringe, Piston
Applicant REPLAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-12
Decision Date1982-09-28

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