First Response Emerg. Eye Injuries

FDA 510(k) K841900 · Reed Products, Inc.

Substantially Equivalent

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)

Official FDA 510(k) record

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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K964029Emergency Relief Kit SystemLRR · Traditional Baxter Healthcare Corp03/17/1997SEKD
K952561Water Jel Burn KitLRR · Traditional Water-Jel Technologies, Inc.07/14/1995SE
K940249Certiburn Burn/Trauma Face Dressing /Towel DressingLRR · Traditional Certified Safety Mfg., Inc.10/03/1994SEKD
K941311First Aid/Truma KitLRR · Traditional Certified Safety Mfg., Inc.06/14/1994SE
K931058Tick-Attack(Tm) KitLRR · Traditional Mind Mechanics, Inc.03/01/1994SESK
K931634Various KitsLRR · Traditional Polymint Industrial Co. , Ltd.11/30/1993SEKD
K921762Shawnee Products Kit ILRR · Traditional Absentee Shawnee Bandage Group01/06/1993SEKD
K903393Auto First-Aid Kit for AmericaLRR · Traditional Hisler-Radke, Inc.01/31/1991SESK
K896413Combination 6X-MAGNIFIER and TweezersLRR · Traditional James Alexander Corp.02/01/1990SE
K895767Original Tick KIT/1ST Aid KitLRR · Traditional Tick Kit, Inc.12/22/1989SESD

More from Tick Kit, Inc.

510(k)DeviceDecision
K841898First Response Emerg. Medicsl - BurnsFPY · Traditional 08/14/1984SE
K841899First Response Emerg. Medical Sys BonesKGX · Traditional 07/23/1984SE
K841897First Response Emerg. Medical SystemKGX · Traditional 07/23/1984SE

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.