510(k) K842015
K842015 is an FDA 510(k) premarket notification submitted by Saffeta, Inc. for the device "SAWYER FIRST AID KIT". The FDA issued a decision of Substantially Equivalent on July 6, 1984. The device falls under product code KYP (Snake Bite Suction Kit), a Class I device regulated under 21 CFR 880.5740.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1984
- Date Received
- May 18, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snake Bite Suction Kit
- Device Class
- Class I
- Regulation Number
- 880.5740
- Review Panel
- HO
- Submission Type
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.