OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
FDA 510(k) clearance K952363 · decided 1995-08-15
Clearance details
- K-number
- K952363
- Device name
- OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
- Applicant
- Ela Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-01
- Decision date
- 1995-08-15
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- ELA
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Minnetonka, MN, 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 |
|---|---|---|
| TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES (K854168) | Travenol Laboratories, S.A. | 1986-03-13 |
| DENTAL INSTRUMENTS - CUTTING INSTRUMENT (K823326) | Miltex, Inc. | 1982-11-24 |
| ANALYTIC TECH. METAL POINT HEATER #3001 (K801974) | Analytic Technology | 1980-11-12 |
Recalls involving this device
No recalls on record reference this clearance.