510(k) K840312
K840312 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "CAT. 8 DENTAL DEVICES". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code EMG (Forceps, Tooth Extractor, Surgical), a Class I device regulated under 21 CFR 872.4565. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1984
- Date Received
- January 24, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Tooth Extractor, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type