510(k) K081721

Device
TRICOS A RESORBABLE SUBSTITUTE
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K081721
Product code
LYC  
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-06
Date received
2008-06-18
Regulation
872.3930
Classification name
Bone Grafting Material, Synthetic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
BARBARA K BARBEAU
Address
1620 Waukegan Rd. Mcgaw Park IL US 60085 60085

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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