510(k) K022836
- Device
- STEPHENS DISPOSABLE SPECULUM
- Applicant
- Stephens Instruments
- 510(k) number
- K022836
- Product code
- HNC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-01
- Date received
- 2002-08-27
- Regulation
- 886.4350
- Classification name
- Specula, 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#
- 3012421607
- 3011659857
- 9616088
- 3017857440
- 3010155661
- 9616250
- 3016069968
- 3013358456
- 3027683457
- 3007583964
- 8044098
- 9681540
- 3005809810
- 1424263
- 3003972428
- 1313700
- 3002991496
- 3015451162
- 3033536312
- 3011137372
- 9680620
- 3009703496
- 9616972
- 1211998
- 3003803182
- 3002675176
- 3004467263
- 3016096142
- 3013398127
- 3015972897
- 9611112
- 3009027787
- 3008280196
- 3008338766
- 3011499367
- 3003365815
- 2085081
- 1036836
- 3001620590
- 3031564283
- 3013602181
- 3007589150
- 3015895045
- 3009732568
- 3027187888
- 3009513193
- 1054811
- 2248180
- 1929756
- 1058726
- 8040382
- 3003039352
- 9615659
- 1417592
- 3023657851
- 3035678069
- 3008754084
- 3013938829
- 3019541696
- 1720747
- 3008812251
- 9615745
- 3013466775
- 3004571672
- 3015512299
- 2085143
- 9680519
- 3029990829
- 3006380247
- 3012733432
- 3017970077
- 1045379
- 8043368
- 1450662
- 3008618183
- 3013503739
- 3004215117
- 3010041511
- 3006541044
Source Documents#
Other 510(k) Records For Product Code HNC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981235 | OCULOSTAT | Laser Center Dev. Corp. | 1998-07-15 |
| K964289 | EYE FIXATION SPECULUM | Eyefix, Inc. | 1996-12-17 |
| K863989 | THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) | Keeler Instruments, Inc. | 1986-10-31 |
| K863664 | OPHTHALMIC SURGICAL SPECULUM | Myocure, Inc. | 1986-09-25 |
| K843196 | VISITEC EYE SPECULUM | Visitec Co. | 1984-10-05 |
| K830430 | EYELID SPECULUM | Douglas C. Mckee & Co. | 1983-06-10 |
| K801969 | ASNIS GUIDED SCREW SYSTEMS | Howmedica Corp. | 1980-08-27 |
| K760847 | FELDSTEIN BLEPHAROPLASTY CLIP SHARP P | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| K760848 | FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |
| K760849 | FELDSTEIN BLEPHAROSTOMY CLIP SQUARE | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-02 |