PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1— 510(k) K911104
Substantially EquivalentHgm Medical Laser Systems, Inc.
FDA 510(k) clearance K911104 for PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1, Substantially Equivalent on 1991-06-11. Applicant: Hgm Medical Laser Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Hgm Medical Laser Systems, Inc.
- Product code
- Code FEX
- Device class
- Class 1
- Regulation
- 21 CFR 876.5090
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code FEX
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