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#
- 3014334038
- 3005595283
- 3015895045
- 3036795921
- 3004475955
- 9680519
- 3003972428
- 8010694
- 3003365815
- 1935627
- 9611502
- 3007507973
- 3004215117
- 1421879
- 3012421607
- 3042940336
- 3019924
- 3013503739
- 3008812251
- 3013358456
- 8040381
- 9611516
- 9616250
- 1211998
- 3011499367
- 8010099
- 3002834291
- 8043368
- 3003418325
- 9680620
- 3008342610
- 3008102042
- 3005528784
- 1934420
- 3042228518
- 3011110913
- 3003407244
- 9612075
- 3033536312
- 1045379
- 9611503
- 1421101
- 8040278
- 3005225959
- 3003860763
- 3004598675
- 1929756
- 3027556548
- 1036836
- 1226587
- 3000264417
- 3011371465
- 3004467263
- 9610612
- 1054811
- 3012733432
- 3031231776
- 1450662
- 1424263
- 3027683457
- 3008770252
- 3008808084
- 1056350
- 1057946
- 9614069
- 3013938829
- 3031564283
- 3015512299
- 3003553186
- 9615857
- 3011600579
- 3002807310
- 8043441
- 9615659
- 3006541044
- 2085143
- 1313525
- 3008338766
- 2028159
- 3017970077
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 |