510(k) K931634
K931634 is an FDA 510(k) premarket notification submitted by Polymint Industrial Co. , Ltd. for the device "VARIOUS KITS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 30, 1993. The device falls under product code LRR (First Aid Kit With Drug), a Class N device. Polymint Industrial Co. , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- November 30, 1993
- Date Received
- April 1, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- First Aid Kit With Drug
- Device Class
- Class N
- Regulation Number
- Review Panel
- SU
- Submission Type
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.