OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER— 510(k) K912522
Substantially EquivalentSummit Technology, Inc.
FDA 510(k) clearance K912522 for OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER, Substantially Equivalent on 1991-07-25. Applicant: Summit Technology, Inc.. Device class: 1.
Clearance details
- Applicant
- Summit Technology, Inc.
- Product code
- Code EQH
- Device class
- Class 1
- Regulation
- 21 CFR 874.4350
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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