KESTREL NO. 695 HEATER
FDA premarket approval P820087/S011 · decided 1988-06-17
Approval details
- PMA number
- P820087
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KESTREL NO. 695 HEATER
- Generic name
- Accessories, soft lens products
- Applicant
- Atrion Medical Products, Inc.
- Date received
- 1987-12-22
- Decision date
- 1988-06-17
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Arab, AL
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QL LOCKING SYRINGE (K060643) | Atrion Medical Products, Inc. | 2006-07-12 |
| ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (K043249) | Atrion Medical Products, Inc. | 2005-05-25 |
| ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (K041158) | Atrion Medical Products, Inc. | 2004-06-16 |
| ATRION MEDICAL QL INFLATION DEVICE (K032840) | Atrion Medical Products, Inc. | 2004-03-03 |
| ATRION MEDICAL QL FLUID DISPENSING SYRINGE (K020333) | Atrion Medical Products, Inc. | 2002-04-25 |
| ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (K973633) | Atrion Medical Products, Inc. | 1998-01-16 |
| ATRION MEDICAL COATED LACRIMAL INTUBATION SET (K973872) | Atrion Medical Products, Inc. | 1998-01-08 |
| ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (K972964) | Atrion Medical Products, Inc. | 1997-10-10 |