510(k) K841900
K841900 is an FDA 510(k) premarket notification submitted by Reed Products, Inc. for the device "FIRST RESPONSE EMERG. EYE INJURIES". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The device falls under product code LRR (First Aid Kit With Drug), a Class N device. Reed Products, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1984
- Date Received
- May 7, 1984
- 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.