SULFUR HEXAFLUORIDE
FDA premarket approval P900067 · decided 1993-02-25
Approval details
- PMA number
- P900067
- Trade name
- SULFUR HEXAFLUORIDE
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 1990-11-02
- Decision date
- 1993-02-25
- Days to decision
- 846 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ULSPIRA TS™ Nitric Oxide Therapy System (K242374) | Airgas Therapeutics, LLC | 2025-01-17 |