FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE SALINE SOLUTION
K Number: K843797
·
Decision Jan 18, 1985
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
6
Review Days
113
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Basic Information
- Device Name
- STERILE SALINE SOLUTION
- K Number
- K843797
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Paco Pharmaceutical Services, Inc.
- Date Received
- September 27, 1984
- Decision Date
- January 18, 1985
- Product Code
- BSY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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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 |
| K843796 | STERILE WATER | Dec 10, 1984 | Substantially Equivalent |
| K761093 | BANDAGE | Jan 6, 1977 | Substantially Equivalent |