Conphar Eye Protector
FDA 510(k) K803145 · Conphar, Inc.
510(k) numberK803145
Submission
- Device name
- Conphar Eye Protector
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- December 12, 1980
- Decision date
- February 5, 1981
- 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 |
|---|---|---|
| K821825 | Conphar Silicone Feeding TubeKNT · Traditional | 08/10/1982SE |
| K821354 | Conphar Mayo Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821295 | Olsen Hegar Needle HoldersGDF · Traditional | 06/03/1982SE |
| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
Questions and answers
When was Conphar Eye Protector cleared by the FDA?
Conphar Eye Protector (K803145) received a 510(k) decision of Substantially Equivalent on February 5, 1981, 55 days after the submission was received.
What is the product code of K803145?
The FDA product code is HMP – Pad, Eye, a Class I (low risk) device regulated under 21 CFR 878.4440.