Eye Pads
FDA 510(k) K802799 · Secol Co.
510(k) numberK802799
Submission
- Device name
- Eye Pads
- Applicant
- Secol Co.
Mchenry, IL, US - Received
- November 4, 1980
- Decision date
- December 17, 1980
- 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 |
|---|---|---|
| K802790 | SolvalineKKX · Traditional | 02/13/1981SE |
| K810111 | Cellona Plaster VarnishITG · Traditional | 02/04/1981SE |
| K810110 | Cobbler's Chip SplintsLGF · Traditional | 01/26/1981SE |
| K810109 | Metal SplintsILH · Traditional | 01/26/1981SE |
| K802794 | Pro-Ophta SticksHOZ · Traditional | 12/22/1980SE |
| K802793 | Lomatuell Ointment DressingNAE · Traditional | 12/18/1980SE |
| K802797 | O.R. DrapesKKX · Traditional | 12/17/1980SE |
| K802791 | Zinc Paste BandageFRO · Traditional | 12/17/1980SE |
| K802787 | Metalline DressingsKKX · Traditional | 12/17/1980SE |
| K802786 | Poroplast-Eye DressingHOY · Traditional | 12/17/1980SE |
Questions and answers
When was Eye Pads cleared by the FDA?
Eye Pads (K802799) received a 510(k) decision of Substantially Equivalent on December 17, 1980, 43 days after the submission was received.
What is the product code of K802799?
The FDA product code is HMP – Pad, Eye, a Class I (low risk) device regulated under 21 CFR 878.4440.