510(k) K853359
- Device
- Reliance 1379
- Applicant
- DENTSPLY INTL.
- 510(k) number
- K853359
- Product code
- HRJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-24
- Date received
- 1985-08-12
- Regulation
- 886.4855
- Classification name
- Table, Instrument, Powered, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SEMMELMAN
- Address
- 96 Caldwell Dr. Cincinnati OH US 45216 45216
FDA Registration Numbers#
- 3009275598
- 3003288808
- 3004784203
- 3010726802
- 3002807715
- 3008197763
- 2242863
- 3015478295
- 3005405896
- 3003851947
- 3013436538
- 1000466215
- 3014326859
- 3004095901
- 3005771344
- 1836161
- 3006142326
- 9710516
- 3010673832
- 3005785090
- 3015746786
- 3030516433
- 9615030
- 3011898560
- 9611269
- 2031962
- 8030392
- 3007343325
- 3006550126
- 3012850581
- 3010774780
- 2939653
- 9710128
- 3015972897
- 3015399802
- 9614661
- 3005755367
- 2918630
- 3010755771
- 3007817024
- 3007085310
- 3009515444
- 8020986
- 3008156177
- 2936921
- 3013148497
- 9616199
- 9617474
- 9710340
- 3020723591
- 3013515803
- 3033566
- 3004441848
- 3006105501
- 3003951061
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HRJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930447 | MARCO H AND TS-1 INSTRUMENT TABLES | Marco Ophthalmic, Inc. | 1993-07-06 |
| K922242 | 910T MONTORIZED INSTRUMENT TABLE | R.H. Burton Co. | 1992-09-30 |
| K912134 | TBD, LENS MEASURING DEVICE | Alcon Laboratories | 1991-07-25 |
| K853744 | TECHNA VISION, INC.ELECTRIC TABLE | Techna Vision | 1985-10-17 |
| K841760 | WOODLYN CLASSIC INSTRUMENT STAND | Woodlyn, Inc. | 1984-06-19 |
| K833820 | MACHEMER/TANO ROTATING | Optical Micro Systems, Inc. | 1984-01-04 |