Ampco Opthalmic Tray
FDA 510(k) K842983 · Associated Medical Products Co.
510(k) numberK842983
Submission
- Device name
- Ampco Opthalmic Tray
- Applicant
- Associated Medical Products Co.
Mchenry, IL, US - Received
- July 30, 1984
- Decision date
- May 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOZ – Sponge, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4790
- Specialty
- Ophthalmic
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|---|---|---|---|
| K132796 | Suntouch Eye SpearHOZ · Traditional | Huizhou Foryou Medical Devices Co., Ltd. | 10/30/2013SE |
| K130117 | Network Eye Spears, Points, Drains, Wicks and ShieldsHOZ · Traditional | Network Medical Products, Ltd. | 10/29/2013SE |
| K091240 | Alphamed Surgical Spear, Model 70-5000HOZ · Traditional | Alphamed, Inc. | 10/23/2009SE |
| K082460 | Cenefom Pva Surgical SpearHOZ · Traditional | Longtek Scientific Co., Ltd. | 12/15/2008SE |
| K012196 | Ultracell Absorbent StickHOZ · Traditional | Ultracell Medical Technologies, Inc. | 08/24/2001SE |
| K011191 | Merocel Cornell Lid and Lash Guard, Merocel and Kerocel Ophthalmic SpongesHOZ · Traditional | Medtronic Xomed, Inc. | 06/26/2001SE |
| K003842 | Prescott's Surgical SpearHOZ · Traditional | Prescott'S, Inc. | 04/13/2001SE |
| K002279 | ML Eye Spear, Model ML 27 EsHOZ · Traditional | Med-Logics, Inc. | 08/18/2000SE |
| K993883 | M-Pact Corneal Light ShieldHOZ · Traditional | M-Pact Corp. | 12/21/1999SE |
| K990671 | Drainage Wick; Surgical Spears and Sponges, Corneal Light Shield, Instrument WipeHOZ · Traditional | Hurricane Medical | 05/10/1999SE |
More from Hurricane Medical
| 510(k) | Device | Decision |
|---|---|---|
| K932221 | Neurological or Crani Trays (Packs)LRO · Traditional | 03/19/1997SE |
| K932216 | C-Section, Labor & Delivery Trays (Packs)MLS · Traditional | 04/19/1994SESK |
| K930507 | Custom Orthopaedic Trays (Packs)HTS · Traditional | 02/22/1994SE |
| K932217 | Major, Minor, Basin Trays (Packs)LRO · Traditional | 11/15/1993SESK |
| K932220 | Lap Choly Trays (Packs)LRO · Traditional | 09/27/1993SESK |
| K932218 | Cardiac Cath or Angiographic TraysDQO · Traditional | 08/27/1993SEKD |
| K932219 | Suture Set or Laceration Trays (Packs)KDD · Traditional | 07/09/1993SESK |
| K843114 | Ampco Procedure Trays / Packs · Traditional | 08/08/1984SESP |
| K823839 | Ampco Kidney Dialysis TrayKOC · Traditional | 03/29/1983SE |
| K821579 | Skin Scrub-TrayLDR · Traditional | 07/21/1982SE |
Questions and answers
When was Ampco Opthalmic Tray cleared by the FDA?
Ampco Opthalmic Tray (K842983) received a 510(k) decision of Substantially Equivalent on May 22, 1985, 296 days after the submission was received.
What is the product code of K842983?
The FDA product code is HOZ – Sponge, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4790.