OH-HARRIS
FDA 510(k) clearance K801388 · decided 1980-07-28
Clearance details
- K-number
- K801388
- Device name
- OH-HARRIS
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-13
- Decision date
- 1980-07-28
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KIH
- Device class
- 1
- Regulation number
- 888.4200
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMARTMIX PRE-FILLED MIXING SYSTEM (K042591) | DePuy Orthopaedics, Inc. | 2004-10-22 |
| P.F.C. CEMENT PRESSURIZING SYSTEM (K943906) | Johnson & Johnson Professionals, Inc. | 1994-12-21 |
| CMW CEMENT PRESSURISATION SYSTEM (K897134) | Dentsply Intl. | 1990-03-02 |
| ORTHOPEADIC CEMENT DELIVERY SYSTEM (K851881) | Dentsply Intl. | 1985-06-13 |
| PRESSURIZING/SCAVENGING ACRYLIC CEMENT (K840046) | Precision Medical Devices, Inc. | 1984-02-09 |
| BRIGHAM TIBIAL CEMENT PRESSURIZER (K833675) | Howmedica Corp. | 1983-12-12 |
| HOWMEDICA FEMORAL PRESSURING SEAL (K811317) | Howmedica Corp. | 1981-05-29 |
| GUN, EXETER CEMENT (K790275) | Howmedica Corp. | 1979-02-21 |
| GUN, CEMENT (K781955) | Depuy, Inc. | 1978-12-04 |
| BONE CEMENT APPLICATOR (K780266) | Zimmer, Inc. | 1978-02-28 |
Recalls involving this device
No recalls on record reference this clearance.