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#
- 3023657851
- 9611112
- 3005440795
- 3007507973
- 3019924
- 3004215117
- 2431166
- 3005595283
- 9615857
- 3008828237
- 1421879
- 1056350
- 3008342610
- 3009703496
- 3007334784
- 3004892425
- 8040278
- 8010099
- 3010041511
- 3035678069
- 3007589150
- 3010687973
- 3009465247
- 2085143
- 1923569
- 3005225959
- 3042228518
- 3008338766
- 3027683457
- 2242450
- 9681540
- 2028159
- 1929756
- 3017970077
- 3007597038
- 3004598675
- 1054811
- 3008618183
- 3010399422
- 3003039352
- 1313525
- 3002991496
- 2320762
- 1054241
- 3015895045
- 1045379
- 1226587
- 3003553186
- 9616245
- 3027556548
- 3002675176
- 8040382
- 3001620590
- 3006380247
- 3012267976
- 3015451162
- 3007583964
- 3008102042
- 1450662
- 3006541044
- 3013358456
- 3006677911
- 3004001706
- 1313700
- 1836161
- 8010694
- 3002807310
- 1036836
- 3004571672
- 3029082594
- 3003951061
- 3031231776
- 9611516
- 3003644849
- 1424263
- 1211998
- 1043214
- 3012421607
- 2529846
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 |