RAPID IMF
FDA 510(k) clearance K030605 · decided 2003-06-27
Clearance details
- K-number
- K030605
- Device name
- RAPID IMF
- Applicant
- Zygomatics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-25
- Decision date
- 2003-06-27
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- DYX
- Device class
- 2
- Regulation number
- 872.4600
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- London Se3 0ta, GB
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| SYNTHES QUICK LOCK IMF SYSTEM (K991004) | Synthes (Usa) | 1999-06-23 |
| IMPLANTABLE PULSE GENERATORS (K925106) | Medtronic Vascular | 1993-10-06 |
| RELIANCE SHORT STICK TIE (K925712) | Reliance Orthodontic Products, Inc. | 1993-01-11 |
| DIMAC WIRES (K910090) | Instrumentations Unltd. | 1991-07-25 |
| JAW FIXATION ASSEMBLY (K863799) | Medical Products & Research, Inc. | 1986-10-14 |
| DENTAL ARCH BAR (K820944) | Unisplint Corp. | 1982-05-05 |
Recalls involving this device
No recalls on record reference this clearance.