BENZETHONIUM CHLORIDE
FDA 510(k) clearance K833903 · decided 1984-05-30
Clearance details
- K-number
- K833903
- Device name
- BENZETHONIUM CHLORIDE
- Applicant
- Blairex Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-14
- Decision date
- 1984-05-30
- Days to decision
- 198 days
- Clearance type
- Traditional
- Product code
- HPX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PMMA CLASIC (K955777) | Rand Scientific Corp. | 1996-05-16 |
| KERATOPLASTY SUTURING LENS (K940106) | Visionary Technologies of Miami, Inc. | 1994-05-25 |
| MULTI-VIEW BIFOCALS (K913081) | Camp Contact Lenses | 1991-10-23 |
| MARTIN-HENSLEY SEGMENT LENS (K897021) | Bruce W. Martin O.D. and Edward Hensley | 1990-06-22 |
| OPTIKEM PMMA CONTACT LENS (K895411) | Optikem Polymers, Inc. | 1990-02-27 |
| ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (K874591) | Vitreo Dynamics, Co. | 1988-05-03 |
| CHARTER HARD CONTACT LENS CLEANING SOLUTION (K865111) | Paco Pharmaceutical Services, Inc. | 1987-01-20 |
| BL1 (HARD CONTACT LENS) (K864343) | Beta Labs, Inc. | 1986-11-28 |
| CHARTER LABORATORIES INC. LENS LUBRICANT (K863974) | Paco Pharmaceutical Services, Inc. | 1986-11-10 |
| CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (K862952) | Paco Pharmaceutical Services, Inc. | 1986-09-25 |
| AQUALUX LENS CASE (K862811) | Safeway Products, Inc. | 1986-09-03 |
| STYLEKEEPER CONTACT LENS CARRYING CASE (K861643) | Allergan, Inc. | 1986-06-02 |
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 |