Instrument, Hand, Calculus Removal
Regulation 872.4565
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ELA
| Company | 510(k)s | Recalls |
|---|---|---|
| Analytic Technology | 1 | 0 |
| Ela Medical, Inc. | 1 | 0 |
| Miltex, Inc. | 1 | 0 |
| Travenol Laboratories, S.A. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 15, 1995 | K952363 | OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) Ela Medical, Inc. | ELA |
| Mar 13, 1986 | K854168 | TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES Travenol Laboratories, S.A. | ELA |
| Nov 24, 1982 | K823326 | DENTAL INSTRUMENTS - CUTTING INSTRUMENT Miltex, Inc. | ELA |
| Nov 12, 1980 | K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 Analytic Technology | ELA |
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