510(k) K834540
K834540 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "OP-CON SURGICAL INSTRUMENT #9". The FDA issued a decision of Substantially Equivalent on Mar 6, 1984. The device falls under product code KBN (Gag, Mouth), a Class I device regulated under 21 CFR 874.4420. Imm Enterprises , Ltd. has 51 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 1984
- Date Received
- Dec 1, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gag, Mouth
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type
- 510(k) Exempt