510(k) K971903
- Device
- SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER
- Applicant
- CONTINUUM BIOMEDICAL, INC.
- 510(k) number
- K971903
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-21
- Date received
- 1997-05-23
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Clearance type
- Traditional
- Third party reviewed
- No
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Legacy Summary#
summary
FDA Review#
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