W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION
FDA 510(k) clearance K872973 · decided 1987-10-15
Clearance details
- K-number
- K872973
- Device name
- W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION
- Applicant
- Wesley Jessen Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-30
- Decision date
- 1987-10-15
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chicago, IL, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| UNISOL PLUS(TM) PH BALANCED SALINE SOLUTION (P790011/S020) | Wesley Jessen Corp. | 1994-12-13 |
| POLYMACON CONTACT LENSES (P820059/S020) | Wesley Jessen Corp. | 1993-11-23 |
| SATURN II(TM) (SYNERGICON A) CONTACT LENS (P840004/S007) | Wesley Jessen Corp. | 1993-10-14 |
| POLYMACON CONTACT LENSES (P820059/S019) | Wesley Jessen Corp. | 1993-09-30 |
| SATURN II(TM) (SYNERGICON A) CONTACT LENS (P840004/S006) | Wesley Jessen Corp. | 1993-05-13 |
| POLYMACON CONTACT LENSES (P820059/S018) | Wesley Jessen Corp. | 1992-03-05 |
| DURASOFT CONTACT LENSES /SHELF LIFE (N17852/S033) | Wesley Jessen Corp. | 1991-10-04 |
| POLYCON CONTACT LENS (N18120/S024) | Wesley Jessen Corp. | 1991-09-06 |