510(k) K840315
K840315 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "CAT 11- GENERAL & PLASTIC SURGERY DEV". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Imm Enterprises , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1984
- Date Received
- January 24, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type