Visitec Eye Shield
FDA 510(k) K843197 · Visitec Co.
510(k) numberK843197
Submission
- Device name
- Visitec Eye Shield
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- August 14, 1984
- Decision date
- October 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMP – Pad, Eye
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4440
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940333 | Eye PadHMP · Traditional | Certified Safety Mfg., Inc. | 03/07/1994SE |
| K921349 | Sterile,Disposable Eye DressingHMP · Traditional | Deroyal Industries, Inc. | 05/29/1992SE |
| K904896 | Eye PadHMP · Traditional | Ulti-Med Intl., Inc. | 12/05/1990SE |
| K883822 | First Aid Kit, Eye Dressing NSN6545-00-853-6309HMP · Traditional | Consolidated Industries of Greater Syracuse, Inc. | 11/22/1988SESD |
| K874411 | Donaldson Natural Eyepatch 'Patient Pak'HMP · Traditional | Keeler Instruments, Inc. | 01/27/1988SE |
| K864810 | LidsplintHMP · Traditional | Precision Therapeutics, Inc. | 01/20/1987SE |
| K861456 | Sheets Lyophilized Collagen HeyedratorHMP · Traditional | Pantheon Products, Inc. | 07/25/1986SN |
| K860979 | Donaldson Natural EyepatchHMP · Traditional | Keeler Instruments, Inc. | 04/04/1986SE |
| K851906 | Surgical Eye PackHMP · Traditional | Xanmed Corp. | 05/21/1985SE |
| K850099 | Visoprotect: Occular ShieldHMP · Traditional | Rockway Enterprises, Inc. | 03/20/1985SE |
More from Rockway Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Visitec Eye Shield cleared by the FDA?
Visitec Eye Shield (K843197) received a 510(k) decision of Substantially Equivalent on October 5, 1984, 52 days after the submission was received.
What is the product code of K843197?
The FDA product code is HMP – Pad, Eye, a Class I (low risk) device regulated under 21 CFR 878.4440.