STERILE SALINE PRESERVED SOLUTION
FDA premarket approval P850070/S009 · decided 1997-06-20
Approval details
- PMA number
- P850070
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STERILE SALINE PRESERVED SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Automatic Liquid Packaging, Inc.
- Date received
- 1997-02-14
- Decision date
- 1997-06-20
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Woodstock, IL
- Statement
- ELIMINATION OF ETHYLENE OXIDE STERILIZATION OF THE PIERCING CAP ATTACHED TO SEALED 12 OZ. AND 16 OZ. CONTAINERS OF STERILE PRESERVED SALINE SOLUTION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321) | Automatic Liquid Packaging, Inc. | 2000-10-25 |
| STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 (K000964) | Automatic Liquid Packaging, Inc. | 2000-04-25 |
| YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION (K980147) | Automatic Liquid Packaging, Inc. | 1998-04-13 |
| IRRIGATION BOTTLE (K973829) | Automatic Liquid Packaging, Inc. | 1998-02-23 |
| HUMIDIFIER ADAPTER (K962079) | Automatic Liquid Packaging, Inc. | 1996-07-31 |
| HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER (K955104) | Automatic Liquid Packaging, Inc. | 1996-06-11 |
| OPTI-MOL FILTERED PUNCTURE PIN (K920306) | Automatic Liquid Packaging, Inc. | 1992-04-06 |
| OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM (K911770) | Automatic Liquid Packaging, Inc. | 1991-10-15 |