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
- 1423662
- 1450662
- 9612300
- 9613348
- 1416980
- 2650143
- 3011936113
- 3002807315
- 3011276344
- 1650372
- 3004464325
- 2032098
- 3008910197
- 1066741
- 3006223010
- 3004142400
- 3011050570
- 3006946279
- 1526439
- 3011649314
- 1319660
- 3015219237
- 9612827
- 3007708799
- 3003771570
- 3010162973
- 2024024
- 3002807314
- 9615788
- 2249852
- 1223843
- 2530154
- 3003300673
- 9710629
- 9610964
- 9681465
- 1058584
- 3006540014
- 1030489
- 3011824442
- 1000194445
- 3002807310
- 2032542
- 1410097
- 3007663067
- 3004681519
- 3009417901
- 3004024955
- 1928237
- 3015780293
- 1319639
- 3008812560
- 9681254
- 2245304
- 3004203816
- 3007225376
- 3003768919
- 3010160527
- 2431866
- 3011795235
- 8030965
- 3021912300
- 3017036472
- 1647149
- 3012447612
- 1220477
- 3006017180
- 3004450973
- 3038718579
- 1225112
- 3007490610
- 3004525100
- 2219920
- 1037007
- 2029275
- 3008114965
- 3016050940
- 3004431266
- 2024311
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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