Resurface Proshesis
FDA 510(k) K781343 · Aesculap Instruments Corp.
510(k) numberK781343
Submission
- Device name
- Resurface Proshesis
- Applicant
- Aesculap Instruments Corp.
Mchenry, IL, US - Received
- August 4, 1978
- Decision date
- September 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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|---|---|---|
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| K880704 | Cerullo Suction RegulatorGCX · Traditional | 03/29/1988SE |
| K860016 | Aesculap Bone MillLYS · Traditional | 03/19/1986SE |
| K801888 | Handpiece, DentalDZA · Traditional | 08/20/1980SE |
| K801887 | Drill, DentalDZA · Traditional | 08/20/1980SE |
| K801886 | Burr, DentalEJL · Traditional | 08/20/1980SE |
Questions and answers
When was Resurface Proshesis cleared by the FDA?
Resurface Proshesis (K781343) received a 510(k) decision of Substantially Equivalent on September 27, 1978, 54 days after the submission was received.