510(k) K231604
- Device
- Instrument Case
- Applicant
- Cochlear Americas
- 510(k) number
- K231604
- Product code
- KCT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-24
- Date received
- 2023-06-01
- Regulation
- 880.6850
- Classification name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Whitney Alexander
- Address
- 10350 Park Meadows Dr. Lone Tree CO US 80124 80124
FDA Registration Numbers
- 1222780
- 3010772758
- 1056553
- 9610612
- 2919128
- 3011373951
- 3006948427
- 3014334038
- 1835444
- 1423662
- 1057421
- 3015181082
- 3013177549
- 3011575197
- 3007389669
- 2431166
- 3020584246
- 3006540014
- 3012085539
- 3001617766
- 8010177
- 3004080920
- 3003394627
- 3009307953
- 3014967149
- 3026612481
- 3011050570
- 3015537048
- 3043237009
- 2020601
- 3009110133
- 1418005
- 3010202439
- 2936485
- 2084725
- 3018094310
- 3009968482
- 3043164947
- 1421101
- 3009973505
- 3015895045
- 3008693672
- 3027345187
- 3020767943
- 3014553709
- 1043653
- 3009540749
- 1221053
- 3005083075
- 3004608878
- 3008868758
- 3001675293
- 3005741909
- 3002808270
- 3027665899
- 3006846433
- 3003990090
- 2031966
- 1032347
- 9611102
- 3008517893
- 1219930
- 8043792
- 3014003062
- 9710524
- 3013188547
- 3005282635
- 9611959
- 3002259632
- 3005004799
- 1923569
- 3008132392
- 3012055599
- 3008812560
- 3006783837
- 1319130
- 3017155536
- 9611274
- 9617111
- 1058020
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09321502043953 | Instrument Case | Cochlear Bone Anchored Solutions AB | 2023-05-19 |
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| K243128 | Klockner Kits | SOADCO, S.L. | 2024-12-18 |
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