Eye Applicators CAT.#980-983
FDA 510(k) K802016 · Pollak (Intl.), Ltd.
510(k) numberK802016
Submission
- Device name
- Eye Applicators CAT.#980-983
- Applicant
- Pollak (Intl.), Ltd.
Walker, MI, US - Received
- August 20, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXF – Applicator, Absorbent Tipped, Non-Sterile
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6025
- Specialty
- General Hospital
Other 510(k)s with product code KXF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123184 | Finn Chambers AquaKXF · Traditional | Smartpractice | 12/19/2012SE |
| K103409 | Allergeaze R ClearKXF · Traditional | Smartpractice | 03/15/2011SE |
| K063160 | Allergeaze Patch Test ChambersKXF · Traditional | Smartpractice | 12/22/2006SE |
| K013820 | Finn Chamber (R)KXF · Traditional | Epitest Ltd. OY | 01/30/2002SE |
| K992553 | Iq ChambersKXF · Traditional | Dormer Laboratories, Inc. | 04/12/2000SE |
| K870762 | Ear Applicator, Catalog No. 2229KXF · Traditional | Treace Medical, Inc. | 03/06/1987SE |
| K843720 | Cotton Tipped Applicators, SingleKXF · Traditional | Abco Dealers, Inc. | 10/04/1984SE |
| K820962 | Cotton SwabsKXF · Traditional | Dafoe & Dafoe, Inc. | 04/20/1982SE |
| K813506 | Farrors TMJ Cassette HolderKXF · Traditional | Brell Mar Products, Inc. | 01/29/1982SE |
| K811365 | Hill Top ChamberKXF · Traditional | Hill Top Research, Inc. | 08/20/1981SE |
More from Hill Top Research, 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 Applicators CAT.#980-983 cleared by the FDA?
Eye Applicators CAT.#980-983 (K802016) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 27 days after the submission was received.
What is the product code of K802016?
The FDA product code is KXF – Applicator, Absorbent Tipped, Non-Sterile, a Class I (low risk) device regulated under 21 CFR 880.6025.