WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
FDA 510(k) clearance K083355 · decided 2008-12-29
Clearance details
- K-number
- K083355
- Device name
- WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
- Applicant
- Blairex Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-13
- Decision date
- 2008-12-29
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Columbus, IN, 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 |
|---|---|---|
| BLAIREX STERILE SALINE SOLUTION (P850045/S015) | Blairex Laboratories, Inc. | 1994-05-27 |
| BLAIREX STERILE SALINE SOLUTION (P850045/S016) | Blairex Laboratories, Inc. | 1994-05-27 |
| BLAIREX STERILE SALINE SOLUTION (P850045/S014) | Blairex Laboratories, Inc. | 1989-06-26 |
| BLAIREX STERILE SALINE SOLUTION (P850045/S011) | Blairex Laboratories, Inc. | 1989-05-02 |
| BLAIREX STERILE SALINE SOLUTION (P850045/S013) | Blairex Laboratories, Inc. | 1988-10-28 |
| BLAIREX STERILE SALINE SOLUTION (P850045/S010) | Blairex Laboratories, Inc. | 1988-06-29 |
| BLAIREX STERILE SALINE SOLUTION (P850045/S008) | Blairex Laboratories, Inc. | 1988-02-23 |
| BLAIREX STERILE SALINE SOLUTION (P850045/S006) | Blairex Laboratories, Inc. | 1987-12-30 |