510(k) K823320
- Device
- DENTAL INSTRUMENTS - BONE CHISELS
- Applicant
- MILTEX, INC.
- 510(k) number
- K823320
- Product code
- EML
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-24
- Date received
- 1982-11-08
- Regulation
- 872.4565
- Classification name
- Chisel, Bone, Surgical
- 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#
- 3043355002
- 3003244954
- 8043752
- 9611281
- 3022862651
- 3011215096
- 3010536692
- 3015512299
- 1828464
- 9680026
- 3002675176
- 3014615697
- 9611278
- 3019455
- 3002769835
- 1835998
- 3004892425
- 3005092287
- 1032227
- 3004598675
- 9611367
- 3001146947
- 3025338240
- 3004193466
- 3015895045
- 3019404837
- 9616246
- 3003963832
- 3004992978
- 1835251
- 3008797953
- 1422507
- 3002834291
- 3008808049
- 3012130008
- 3011164188
- 3004168759
- 1057946
- 3009241418
- 3012995405
- 3003334541
- 3011600579
- 3009417901
- 8010733
- 3003988575
- 3003905396
- 3001297506
- 3008770252
- 9610612
- 8043507
- 3030644259
- 3008936260
- 3013552516
- 1056350
- 3007648354
- 3005061536
- 2087382
- 3000286616
- 3003882387
- 3036756245
- 9613926
- 3001620590
- 3003877407
- 3000270450
- 3017521423
- 3031564283
- 8040278
- 9611274
- 3008261720
- 3005273623
- 3001644167
- 3008812560
- 3010687973
- 2431166
- 3007064566
- 2246990
- 3010288346
- 3010041511
- 3017352116
- 3025603301
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EML #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851715 | 830/4 TO 848/7 VARIOUS TYPES CHISELS | Artiberia | 1985-06-11 |
Legacy Summary#
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FDA Review#
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