FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STERILE WATER
K Number: K843796
·
Decision Dec 10, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
74
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Basic Information
- Device Name
- STERILE WATER
- K Number
- K843796
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Paco Pharmaceutical Services, Inc.
- Date Received
- September 27, 1984
- Decision Date
- December 10, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by Paco Pharmaceutical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K865111 | CHARTER HARD CONTACT LENS CLEANING SOLUTION | Jan 20, 1987 | Substantially Equivalent |
| K863974 | CHARTER LABORATORIES INC. LENS LUBRICANT | Nov 10, 1986 | Substantially Equivalent |
| K862952 | CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES | Sep 25, 1986 | Substantially Equivalent |
| K843797 | STERILE SALINE SOLUTION | Jan 18, 1985 | Substantially Equivalent |
| K761093 | BANDAGE | Jan 6, 1977 | Substantially Equivalent |