SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2— 510(k) K083780
Substantially EquivalentAudio Technologies S.R.L.
FDA 510(k) clearance K083780 for SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2, Substantially Equivalent on 2009-03-23. Applicant: Audio Technologies S.R.L.. Device class: 2.
Clearance details
- Applicant
- Audio Technologies S.R.L.
- Product code
- Code ETA
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Piacenza, IT
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