510(k) K911104
- Device
- PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1
- Applicant
- HGM MEDICAL LASER SYSTEMS, INC.
- 510(k) number
- K911104
- Product code
- FEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-06-11
- Date received
- 1991-03-13
- Regulation
- 876.5090
- Classification name
- Instrument, Catheter, Punch
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENNIS REIGLE
- Address
- 3959 W. 1820 S. Salt Lake City UT US 84104 84104
FDA Registration Numbers#
- 8030607
- 9613926
- 1836161
- 3001644167
- 1820334
- 8040278
- 3009688853
- 1825146
- 9611112
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FEX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K771725 | BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. | Xomed, Inc. | 1977-09-26 |
Legacy Summary#
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FDA Review#
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