SURGITRON— 510(k) K955158
Substantially EquivalentEllman Intl., Inc.
FDA 510(k) clearance K955158 for SURGITRON, Substantially Equivalent on 1996-02-09. Applicant: Ellman Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Ellman Intl., Inc.
- Product code
- Code HQR
- Device class
- Class 2
- Regulation
- 21 CFR 886.4100
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sound Beach, NY, US
Recent devices under product code HQR
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