510(k) K834361
K834361 is an FDA 510(k) premarket notification submitted by C.B.S. Biotechnics, Inc. for the device "JSB JET SYRINGE". The FDA issued a decision of Substantially Equivalent on March 5, 1984. The device falls under product code EGM (Injector, Jet, Mechanical-Powered), a Class II device regulated under 21 CFR 872.4475. C.B.S. Biotechnics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1984
- Date Received
- October 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector, Jet, Mechanical-Powered
- Device Class
- Class II
- Regulation Number
- 872.4475
- Review Panel
- DE
- Submission Type