510(k) K834541
K834541 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48". The FDA issued a decision of Substantially Equivalent on Jan 27, 1984. The device falls under product code GDX (Scalpel, One-Piece), a Class I device regulated under 21 CFR 878.4800. Imm Enterprises , Ltd. has 51 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 27, 1984
- Date Received
- Nov 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Scalpel, One-Piece
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt