510(k) K924993
- Device
- GLENROE BAND SEATING CONTOURING INSTRUMENT
- Applicant
- GLENROE TECHNOLOGIES
- 510(k) number
- K924993
- Product code
- ECS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-11-25
- Date received
- 1992-10-01
- Regulation
- 872.4565
- Classification name
- Pusher, Band, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN F BOZMAN
- Address
- 1912 44th Ave. E Bradenton FL US 34203 34203
FDA Registration Numbers#
- 8043622
- 9681207
- 9611278
- 9611503
- 1718476
- 1057946
- 3003882387
- 3004168759
- 3004992978
- 9611458
- 9710524
- 9611367
- 3016965929
- 3005092287
- 3003418325
- 3013508670
- 1032347
- 3003244954
- 3003877407
- 3012477813
- 9614075
- 2024980
- 3035708926
- 2246990
- 9610905
- 3009968482
- 9710113
- 3004776555
- 3014334038
- 3029683441
- 3003969055
- 3004158247
- 3007616048
- 3016998377
- 9614986
- 3005067367
- 3009340886
- 1836161
- 8010591
- 8040233
- 3034693059
- 3009827000
- 3016543896
- 3014829979
- 1422507
- 8040278
- 2080222
- 3008936260
- 3014937043
- 3010442693
- 3004193466
- 9611283
- 3015176311
- 1036212
- 3008648418
- 3008959450
- 8041151
- 3007962015
- 3021666757
- 2126683
- 3004753334
- 1416605
- 3009171220
- 3036795921
- 3010236732
- 3001561923
- 3013497507
- 3015266919
- 1419489
- 3014683120
- 3010032042
- 3013552516
- 5906
- 3014270297
- 3032027578
- 9681622
- 3005809810
- 3017910185
- 9610809
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ECS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935155 | MERSHON BAND PUSHER | Dentauraum, Inc. | 1994-02-04 |
Legacy Summary#
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FDA Review#
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