ENDOVIEW SPPHIRE LENS SET— 510(k) K971853
Substantially EquivalentAmerican Medical Devices, Inc.
FDA 510(k) clearance K971853 for ENDOVIEW SPPHIRE LENS SET, Substantially Equivalent on 1997-08-06. Applicant: American Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- American Medical Devices, Inc.
- Product code
- Code HJK
- Device class
- Class 2
- Regulation
- 21 CFR 886.1385
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Atlanta, GA, US
Recent devices under product code HJK
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Data sourced from openFDA. This site is unofficial and independent of the FDA.