Feldstein Blepharostomy Clip Square
FDA 510(k) K760849 · V. Mueller O.V. Baxter Healthcare Corp.
510(k) numberK760849
Submission
- Device name
- Feldstein Blepharostomy Clip Square
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
Mchenry, IL, US - Received
- October 15, 1976
- Decision date
- November 2, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNC – Specula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022836 | Stephens Disposable SpeculumHNC · Traditional | Stephens Instruments | 11/01/2002SE |
| K981235 | OculostatHNC · Traditional | Laser Center Dev. Corp. | 07/15/1998SE |
| K964289 | Eye Fixation SpeculumHNC · Traditional | Eyefix, Inc. | 12/17/1996SE |
| K863989 | Thornton Titanium Speculum (Modified Barraquer)HNC · Traditional | Keeler Instruments, Inc. | 10/31/1986SE |
| K863664 | Ophthalmic Surgical SpeculumHNC · Traditional | Myocure, Inc. | 09/25/1986SE |
| K843196 | Visitec Eye SpeculumHNC · Traditional | Visitec Co. | 10/05/1984SE |
| K830430 | Eyelid SpeculumHNC · Traditional | Douglas C. Mckee & Co. | 06/10/1983SE |
| K801969 | Asnis Guided Screw SystemsHNC · Traditional | Howmedica Corp. | 08/27/1980SE |
| K760848 | Feldstein Blepharoplasty Clip RectanguHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
| K760847 | Feldstein Blepharoplasty Clip Sharp PHNC · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/02/1976SE |
More from V. Mueller O.V. Baxter Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K803292 | Field Suction DissectorGDI · Traditional | 01/29/1981SE |
| K792383 | Kelman DipstickHOE · Traditional | 12/11/1979SE |
| K771197 | Norton EndotrachealBTR · Traditional | 08/16/1977SE |
| K771302 | Pfister-Schwartz Stone RetrieverFGO · Traditional | 08/02/1977SE |
| K770959 | Bougie, Filiform, JacksonKBI · Traditional | 06/14/1977SE |
| K770280 | Cord, Electrosurgical-Sterile & Dispos.KNS · Traditional | 04/15/1977SE |
| K760851 | Converse Altar RetractorKAL · Traditional | 03/10/1977SE |
| K761242 | Teflon Coated Resectoscope SheathFJL · Traditional | 12/16/1976SE |
| K760273 | LithotriteFGK · Traditional | 12/06/1976SE |
| K760189 | Stopcock, WaterlineFAJ · Traditional | 12/02/1976SE |
Questions and answers
When was Feldstein Blepharostomy Clip Square cleared by the FDA?
Feldstein Blepharostomy Clip Square (K760849) received a 510(k) decision of Substantially Equivalent on November 2, 1976, 18 days after the submission was received.
What is the product code of K760849?
The FDA product code is HNC – Specula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.