First Response Emerg. Eye Injuries
FDA 510(k) K841900 · Reed Products, Inc.
510(k) numberK841900
Submission
- Device name
- First Response Emerg. Eye Injuries
- Applicant
- Reed Products, Inc.
Mchenry, IL, US - Received
- May 7, 1984
- Decision date
- July 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LRR – First Aid Kit With Drug
- Device class
- Not classified
Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at…
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| K921762 | Shawnee Products Kit ILRR · Traditional | Absentee Shawnee Bandage Group | 01/06/1993SEKD |
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| K896413 | Combination 6X-MAGNIFIER and TweezersLRR · Traditional | James Alexander Corp. | 02/01/1990SE |
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Questions and answers
When was First Response Emerg. Eye Injuries cleared by the FDA?
First Response Emerg. Eye Injuries (K841900) received a 510(k) decision of Substantially Equivalent on July 23, 1984, 77 days after the submission was received.
What is the product code of K841900?
The FDA product code is LRR – First Aid Kit With Drug, a Not classified device.