Oh-Harris
FDA 510(k) K801388 · Johnson & Johnson Professionals, Inc.
510(k) numberK801388
Submission
- Device name
- Oh-Harris
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- June 13, 1980
- Decision date
- July 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K943906 | P.F.C. Cement Pressurizing SystemKIH · Traditional | Johnson & Johnson Professionals, Inc. | 12/21/1994SE |
| 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 |
| 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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| K991413 | Codman Ethisorb Dura PatchGXQ · Traditional | 03/13/2000SE |
| K991222 | Codman Microsensor Ventricular Catheter KitGWM · Traditional | 07/09/1999SE |
| K982379 | Sundt Slim-Line Aneurysm Clip ApplierHCI · Traditional | 12/18/1998SE |
| K982812 | G2 Total Hip System Femoral Stem (11/13 Taper)KWY · Traditional | 12/04/1998SE |
| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | 11/06/1998SE |
| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
| K974739 | Hakim Programmable Valve SystemJXG · Traditional | 07/01/1998SE |
| K980801 | J-Fx Bipolar HeadKWY · Traditional | 05/29/1998SE |
Questions and answers
When was Oh-Harris cleared by the FDA?
Oh-Harris (K801388) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 45 days after the submission was received.
What is the product code of K801388?
The FDA product code is KIH – Dispenser, Cement, a Class I (low risk) device regulated under 21 CFR 888.4200.