510(k) K110198
- Device
- BLUE SKY BIO TCP
- Applicant
- BLUE SKY BIO, LLC
- 510(k) number
- K110198
- Product code
- LPK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-22
- Date received
- 2011-01-24
- Regulation
- 872.3930
- Classification name
- Bone Grafting Material, For Dental Bone Repair
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHELE VOVOLKA
- Address
- 888 E. Belvidere Rd. Suite 212 Grayslake IL US 60030 60030
FDA Registration Numbers#
- 3038718579
- 2245304
- 1650372
- 2011171
- 3003775072
- 9610921
- 1221541
- 2032542
- 2081055
- 3027448274
- 3003768919
- 3010162973
- 1223843
- 3015780293
- 3002983930
- 1410097
- 3010160527
- 1030489
- 3002673655
- 1225112
- 8043792
- 3004450973
- 3011649314
- 3004142400
- 3007708799
- 3004847139
- 1450662
- 2024024
- 2249852
- 3004525100
- 1928237
- 3011824442
- 3002807315
- 3002807310
- 3011795235
- 9612300
- 3017036472
- 1319639
- 2024311
- 3007663067
- 2219920
- 3011050570
- 1526439
- 1647149
- 3003418325
- 3004203816
- 3012447612
- 3007490610
- 3006946279
- 3011936113
- 1058584
- 1416980
- 3021912300
- 1037007
- 3002807314
- 1066741
- 9681465
- 2648988
- 3006223010
- 2431866
- 3008114965
- 2029275
- 9612827
- 1319660
- 3009417901
- 3011276344
- 1000194445
- 3003300673
- 3007225376
- 3006540014
- 3004024955
- 3015219237
- 9710629
- 1423662
- 3004464325
- 3003771570
- 1121308
- 2650143
- 3016050940
Source Documents#
Legacy Summary#
summary
FDA Review#
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