APACERAM OSSICULAR PROSTHESIS— 510(k) K893134
Substantially EquivalentAsahi Optical Co. C/O Rosati Associates, P.C.
FDA 510(k) clearance K893134 for APACERAM OSSICULAR PROSTHESIS, Substantially Equivalent on 1989-08-03. Applicant: Asahi Optical Co. C/O Rosati Associates, P.C.. Device class: 2.
Clearance details
- Applicant
- Asahi Optical Co. C/O Rosati Associates, P.C.
- Product code
- Code ETB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3450
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, MI, US
Recent devices under product code ETB
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- K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
More clearances from Asahi Optical Co. C/O Rosati Associates, P.C.
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