TENNANT(TM) & KELMAN(TM) TYPE II
FDA premarket approval P800016/S003 · decided 1985-06-28
Approval details
- PMA number
- P800016
- Supplement
- S003
- Trade name
- TENNANT(TM) & KELMAN(TM) TYPE II
- Generic name
- Transducer, ultrasonic, obstetric
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 1983-12-20
- Decision date
- 1985-06-28
- Days to decision
- 556 days
- Decision code
- APPR
- Product code
- HGL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
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