OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
FDA premarket approval P940010 · decided 1995-12-27
Approval details
- PMA number
- P940010
- Trade name
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 1994-04-13
- Decision date
- 1995-12-27
- Days to decision
- 623 days
- Decision code
- APPR
- Product code
- MVG
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- APPROVAL FOR OPTIGUIDE FIBER OPTIC DIFFUSER, MODELS DCYL 10, DCYL 15, DCYL 25
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