FIRST AID SURVIVAL KIT
Device Facts
| Record ID | K891483 |
|---|---|
| Device Name | FIRST AID SURVIVAL KIT |
| Applicant | Elwyn, Inc. |
| Product Code | LRR · SU |
| Decision Date | May 11, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class N |
Regulatory Classification
Identification
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 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.
