510(k) K943906
K943906 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "P.F.C. CEMENT PRESSURIZING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 1994. The device falls under product code KIH (Dispenser, Cement), a Class I device regulated under 21 CFR 888.4200. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1994
- Date Received
- August 11, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dispenser, Cement
- Device Class
- Class I
- Regulation Number
- 888.4200
- Review Panel
- OR
- Submission Type