STERILE SALINE PRESERVED SOLUTION
FDA premarket approval P850070/S008 · decided 1996-07-10
Approval details
- PMA number
- P850070
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STERILE SALINE PRESERVED SOLUTION
- Generic name
- Accessories, soft lens products
- Applicant
- Automatic Liquid Packaging, Inc.
- Date received
- 1995-11-03
- Decision date
- 1996-07-10
- Days to decision
- 250 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Woodstock, IL
- Statement
- APPROVAL FOR AN ALTERNATE CLOSURE DESIGN WHICH UTILIZES A PIERCING CAP AND "FLIP-TOP" ON 12 OZ. AND 16 OZ. PRESERVED SLINE SOLUTION CONTAINERS ONLY
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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 |