FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
K Number: K980147
·
Decision Apr 13, 1998
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
21
Review Days
88
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Basic Information
- Device Name
- YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
- K Number
- K980147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Automatic Liquid Packaging, Inc.
- Date Received
- January 15, 1998
- Decision Date
- April 13, 1998
- Product Code
- LPN
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |
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Other Clearances by Automatic Liquid Packaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K994321 | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP | Oct 25, 2000 | Substantially Equivalent |
| K000964 | STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 | Apr 25, 2000 | Substantially Equivalent |
| K973829 | IRRIGATION BOTTLE | Feb 23, 1998 | Substantially Equivalent |
| K962079 | HUMIDIFIER ADAPTER | Jul 31, 1996 | Substantially Equivalent |
| K955104 | HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER | Jun 11, 1996 | Substantially Equivalent |
| K920306 | OPTI-MOL FILTERED PUNCTURE PIN | Apr 6, 1992 | Substantially Equivalent |
| K911770 | OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM | Oct 15, 1991 | Substantially Equivalent |
| K901762 | PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM | Jul 17, 1990 | Substantially Equivalent |
| K901362 | ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE | Jun 6, 1990 | Substantially Equivalent |
| K901301 | STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL | May 31, 1990 | Substantially Equivalent |