510(k) K022843
- Device
- GAYHEART CORNEAL EXCISION DEVICE
- Applicant
- Stephens Instruments
- 510(k) number
- K022843
- Product code
- HRH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-01
- Date received
- 2002-08-27
- Regulation
- 886.4350
- Classification name
- Trephine, Manual, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- ARCHANA JOHNSON
- Address
- 2500 Sandersville Rd. Lexington KY US 40511 40511
FDA Registration Numbers#
- 8021817
- 3003039352
- 2029275
- 1000484830
- 3003536766
- 2244478
- 3014334038
- 9615659
- 8040381
- 8043496
- 9616250
- 2431166
- 9614107
- 3018071447
- 3005809810
- 1055890
- 9680518
- 8044098
- 3015177648
- 3030451558
- 3005067367
- 1047843
- 3006234591
- 3015895045
- 1421101
- 3012833022
- 1319639
- 1054241
- 1928237
- 3015218018
- 3016069968
- 1058726
- 1920664
- 3008342610
- 3013421458
- 1055236
- 1313525
- 3007317099
- 3004598675
- 1720747
- 3004858034
- 3009298127
- 9680620
- 9616245
- 1835993
- 1211998
- 1643817
- 8040382
- 3009513193
- 3027556548
- 3013358456
- 8040263
- 3012185136
- 3008719017
- 3010383847
- 8040278
- 1934420
- 3013466775
- 1926681
- 1226587
- 3010399422
- 3008338766
- 3003418325
- 3004475955
- 1836161
- 1043214
- 3004215117
- 3002807310
- 1054811
- 3012733432
- 2031962
- 3005528784
- 9611283
- 3006550126
- 1417592
- 3005370013
- 3008770252
- 1056350
- 9617768
- 3011499367
Source Documents#
Other 510(k) Records For Product Code HRH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K931792 | ARTHROSCOPE | Intramed Laboratories, Inc. | 1994-06-13 |
| K873918 | HEAD & CHIN RESTS | Richmond Products, Inc. | 1987-10-28 |
| K864520 | BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON | Precision Instruments, Inc. | 1987-01-20 |
| K862524 | DEKNATEL (R) TREPHINE | Deknatel, Inc. | 1986-08-11 |
| K861825 | CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE | Storz Instrument Co. | 1986-06-09 |
| K860648 | BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA | Precision Instruments, Inc. | 1986-03-25 |
| K843646 | STEINWAY MICRO-KERATO-TREPHINE | Steinway Instrument Co., Inc. | 1985-01-03 |
| K843048 | RING SUPPORTED TREPHINE FOR CORNEA TRANS | Precision Instruments, Inc. | 1984-10-05 |
| K812723 | PEARCE CORNEAL TREPHINE | Visitec Co. | 1981-10-13 |
| K781411 | CORNEAL CUTTER AND ACCESSORIES | Codman & Shurtleff, Inc. | 1978-09-20 |
| K771866 | TROUTMAN CORNEAL PUNCH | Edward Weck, Inc. | 1977-11-09 |