Sawyer First Aid Kit

FDA 510(k) K842015 · Saffeta, Inc.

Substantially Equivalent

510(k) numberK842015

Submission

Device name
Sawyer First Aid Kit
Applicant
Saffeta, Inc.
Mchenry, IL, US
Received
May 18, 1984
Decision date
July 6, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KYP – Snake Bite Suction Kit
Device class
Class I (low risk)
Regulation
21 CFR 880.5740
Specialty
General Hospital

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other 510(k)s with product code KYP

510(k)DeviceApplicantDecision
K883839Nd:Yag Laser Spectacles, MST Model #YLS-5KYP · Traditional Marlo Surgical Technology12/09/1988SE
K844048Dr. Hessel's Insect Poison RemoverKYP · Traditional Medie Group01/23/1985SE
K831312Lopez-Horn CarrierKYP · Traditional Chiron Vision Corp.05/25/1983SE

Questions and answers

When was Sawyer First Aid Kit cleared by the FDA?

Sawyer First Aid Kit (K842015) received a 510(k) decision of Substantially Equivalent on July 6, 1984, 49 days after the submission was received.

What is the product code of K842015?

The FDA product code is KYP – Snake Bite Suction Kit, a Class I (low risk) device regulated under 21 CFR 880.5740.