PRESSURIZER, EXETER CEMENT
FDA 510(k) clearance K781792 · decided 1979-02-08
Clearance details
- K-number
- K781792
- Device name
- PRESSURIZER, EXETER CEMENT
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-10-25
- Decision date
- 1979-02-08
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- KIZ
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| MULTIWELL CULTURE PLATE INSERTS (K890542) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-02-14 |
| TISSUE CULTURE DISHES (K873891) | Nunc, Inc. | 1987-11-25 |
| TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES (K871483) | Isratech Marketing Corp. | 1987-04-29 |
| CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE (K854724) | Lifetrac, Inc. | 1985-12-13 |
| CORNING CELL WELLS-MULTIPLE WELL PLATES (K853634) | Corning Medical & Scientific | 1985-09-16 |
| REMOVAWELL TISSUE CULTURE PLATE W/LID (K821687) | Dynatech Corp. | 1982-06-24 |
| 120 WELL HISTO-PLATE (K790958) | Dynatech Laboratories, Inc. | 1979-06-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |