510(k) K830775
- Device
- FACEBOW FOR BALANCE ARTICULATOR
- Applicant
- ALMORE INTL., INC.
- 510(k) number
- K830775
- Product code
- KCR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-04-28
- Date received
- 1983-03-11
- Regulation
- 872.3220
- Classification name
- Facebow
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9614733
- 3009496224
- 8010342
- 3005181866
- 2435118
- 3009491780
- 9616978
- 2126683
- 3013934196
- 3005942449
- 3012715571
- 3013519244
- 3004095674
- 3007081532
- 3029973772
- 3003092374
- 3022296393
- 8030870
- 3043149181
- 3007773213
- 3004704962
- 9710113
- 3014683120
- 3004966444
- 3004168759
- 9612352
- 9681207
- 1000493628
- 3010032042
- 1000277456
- 8040278
- 3030515618
- 1043617
- 3007353764
- 3009171220
- 3017352116
- 8021050
- 3001685118
- 3031564283
- 3004730368
- 3012226300
- 9611458
- 8044058
- 3008770252
- 3011511773
- 3015337428
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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