510(k) K834178
K834178 is an FDA 510(k) premarket notification submitted by Imm Enterprises , Ltd. for the device "H.R. JAKOBI SURG. INSTR. #10 34/36". The FDA issued a decision of Substantially Equivalent on Feb 23, 1984. The device falls under product code GWZ (Percussor), a Class I device regulated under 21 CFR 882.1700. Imm Enterprises , Ltd. has 51 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 23, 1984
- Date Received
- Nov 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Percussor
- Device Class
- Class I
- Regulation Number
- 882.1700
- Review Panel
- NE
- Submission Type
- 510(k) Exempt