510(k) K840311
K840311 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "CAT. 7-EAR, NOSE & THROAT DEVICES". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code KCP (Syringe, Ent), a Class I device regulated under 21 CFR 874.5220. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1984
- Date Received
- January 24, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Ent
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type