STERILE WATER
FDA 510(k) clearance K843796 · decided 1984-12-10
Clearance details
- K-number
- K843796
- Device name
- STERILE WATER
- Applicant
- Paco Pharmaceutical Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-27
- Decision date
- 1984-12-10
- Days to decision
- 74 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SORBIC ACID PRESERVED LENS LUBRICANT (P850075/S009) | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| SORBIC ACID PRESERVED DAILY CLEANER (P850076/S009) | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| CHARTER LABS SALINE SOLUTION (P840069/S007) | Paco Pharmaceutical Services, Inc. | 1997-07-02 |
| SORBIC ACID PRESERVED LENS LUBRICANT (P850075/S008) | Paco Pharmaceutical Services, Inc. | 1990-10-31 |
| SORBIC ACID PRESERVED LENS LUBRICANT (P850075/S006) | Paco Pharmaceutical Services, Inc. | 1990-04-12 |
| SORBIC ACID PRESERVED DAILY CLEANER (P850076/S008) | Paco Pharmaceutical Services, Inc. | 1989-11-07 |
| HYDROGEN PEROXIDE DISINFECTION SOLUTION (P850026/S006) | Paco Pharmaceutical Services, Inc. | 1989-11-07 |
| CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC (P850012/S005) | Paco Pharmaceutical Services, Inc. | 1989-11-07 |