Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 Set
FDA 510(k) K990954 · Nsk Nakanishi, Inc.
510(k) numberK990954
Submission
- Device name
- Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 Set
- Applicant
- Nsk Nakanishi, Inc.
Tochigi-Ken, JP - Received
- March 22, 1999
- Decision date
- June 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)EKX · Traditional | 03/24/1999SE |
| K990646 | Portable Electric Motor-Handpiece Unit, Handy-MateEKX · Traditional | 03/19/1999SE |
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| K972924 | Surgic II Implant Control UnitEBW · Traditional | 10/30/1997SE |
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| K970953 | E-Type Speed Reducer Contra AngleKMW · Traditional | 04/15/1997SE |
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Questions and answers
When was Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 Set cleared by the FDA?
Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 Set (K990954) received a 510(k) decision of Substantially Equivalent on June 9, 1999, 79 days after the submission was received.
What is the product code of K990954?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.