P.F.C. Cement Pressurizing System
FDA 510(k) K943906 · Johnson & Johnson Professionals, Inc.
510(k) numberK943906
Submission
- Device name
- P.F.C. Cement Pressurizing System
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- August 11, 1994
- Decision date
- December 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KIH – Dispenser, Cement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4200
- Specialty
- Orthopedic
Other 510(k)s with product code KIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042591 | Smartmix Pre-Filled Mixing SystemKIH · Special | DePuy Orthopaedics, Inc. | 10/22/2004SE |
| K897134 | CMW Cement Pressurisation SystemKIH · Traditional | Dentsply Intl. | 03/02/1990SE |
| K851881 | Orthopeadic Cement Delivery SystemKIH · Traditional | Dentsply Intl. | 06/13/1985SE |
| K840046 | Pressurizing/Scavenging Acrylic CementKIH · Traditional | Precision Medical Devices, Inc. | 02/09/1984SE |
| K833675 | Brigham Tibial Cement PressurizerKIH · Traditional | Howmedica Corp. | 12/12/1983SE |
| K811317 | Howmedica Femoral Pressuring SealKIH · Traditional | Howmedica Corp. | 05/29/1981SE |
| K801388 | Oh-HarrisKIH · Traditional | Johnson & Johnson Professionals, Inc. | 07/28/1980SE |
| K790275 | Gun, Exeter CementKIH · Traditional | Howmedica Corp. | 02/21/1979SE |
| K781955 | Gun, CementKIH · Traditional | Depuy, Inc. | 12/04/1978SE |
| K780266 | Bone Cement ApplicatorKIH · Traditional | Zimmer, Inc. | 02/28/1978SE |
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| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
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Questions and answers
When was P.F.C. Cement Pressurizing System cleared by the FDA?
P.F.C. Cement Pressurizing System (K943906) received a 510(k) decision of Substantially Equivalent on December 21, 1994, 132 days after the submission was received.
What is the product code of K943906?
The FDA product code is KIH – Dispenser, Cement, a Class I (low risk) device regulated under 21 CFR 888.4200.