Eye Pads CAT.#581-599
FDA 510(k) K801995 · Pollak (Intl.), Ltd.
510(k) numberK801995
Submission
- Device name
- Eye Pads CAT.#581-599
- Applicant
- Pollak (Intl.), Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- September 9, 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 |
|---|---|---|
| K000227 | UmbicutHFW · Traditional | 04/27/2000SE |
| K810049 | Pedicat*KMJ · Traditional | 04/21/1981SE |
| K810050 | Vecafix*KGX · Traditional | 03/26/1981SE |
| K802011 | Infussion Alarm System I.A.S. CAT.#1118FLN · Traditional | 10/31/1980SE |
| K802009 | Flowclamp CAT.#1011 & 1012FKK · Traditional | 10/31/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | 10/10/1980SE |
| K802007 | Pediwet=Guaze Impregnated with PetrolFRQ · Traditional | 09/26/1980SE |
| K802022 | Sterile Guaze Swabs CAT.#301-420EFQ · Traditional | 09/16/1980SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | 09/16/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | 09/16/1980SE |
Questions and answers
When was Eye Pads CAT.#581-599 cleared by the FDA?
Eye Pads CAT.#581-599 (K801995) received a 510(k) decision of Substantially Equivalent on September 9, 1980, 20 days after the submission was received.
What is the product code of K801995?
The FDA product code is HMP – Pad, Eye, a Class I (low risk) device regulated under 21 CFR 878.4440.