JAKOBI SURG. INSTRUMENTS #8 15
FDA 510(k) clearance K834190 · decided 1984-03-06
Clearance details
- K-number
- K834190
- Device name
- JAKOBI SURG. INSTRUMENTS #8 15
- Applicant
- Imm Enterprises , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-21
- Decision date
- 1984-03-06
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- EMH
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- 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 |
|---|---|---|
| BONE RONGEUR, DOUBLE-ACTION (K890256) | Kinetic Medical Products | 1989-01-27 |
| BONE RONGEUR, SINGLE-ACTION (K890255) | Kinetic Medical Products | 1989-01-27 |
| MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT (K854887) | Walter Lorenz Surgical, Inc. | 1986-02-28 |
| 586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC (K851710) | Artiberia | 1985-06-11 |
| SURGICAL INSTRUMENTS & ACCESSORIES (K834366) | C.B.S. Biotechnics, Inc. | 1984-02-27 |
| MODIFIED RONGEURS FOR SPINAL & ORTH. S. (K821358) | Downs Surgical , Ltd. | 1982-05-28 |
| FORCEPS, STYLE #849 (K771522) | Premier Dental Products Co. | 1977-08-16 |
Recalls involving this device
No recalls on record reference this clearance.