Eye Pad
FDA 510(k) K904896 · Ulti-Med Intl., Inc.
510(k) numberK904896
Submission
- Device name
- Eye Pad
- Applicant
- Ulti-Med Intl., Inc.
Glendale Hts., IL, US - Received
- October 30, 1990
- Decision date
- December 5, 1990
- 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 |
| 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 |
| K850005 | Visoprotect Occular ShieldHMP · Traditional | M.S.G. Health Systems, Inc. | 03/20/1985SE |
More from M.S.G. Health Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K103011 | Ulticare Safety Insulin SyringeMEG · Traditional | 02/02/2011SE |
| K923176 | Surgical Instrument Kit, DisposableKDD · Traditional | 06/17/1993SE |
| K923175 | Surgical Instrument Kit, DisposableFMC · Traditional | 06/17/1993SE |
| K920989 | Surgical Instrument Kit, DisposableKDD · Traditional | 10/19/1992SEKD |
| K922828 | Ulcer Wound TrayKKX · Traditional | 09/28/1992SEKD |
| K914244 | Sterile Custom Surgical KitsKDD · Traditional | 02/24/1992SEKD |
| K914431 | Absorbent FiberNAB · Traditional | 12/04/1991SE |
| K912693 | Post Operative SpongeNAB · Traditional | 10/04/1991SE |
| K912692 | Conforming BandageNAB · Traditional | 10/04/1991SE |
| K901465 | Absorbable Gauze DrapeKKX · Traditional | 06/12/1990SE |
Questions and answers
When was Eye Pad cleared by the FDA?
Eye Pad (K904896) received a 510(k) decision of Substantially Equivalent on December 5, 1990, 36 days after the submission was received.
What is the product code of K904896?
The FDA product code is HMP – Pad, Eye, a Class I (low risk) device regulated under 21 CFR 878.4440.