THE BOSTON TM CLEANER II
FDA premarket approval P890054/S001 · decided 1994-08-15
Approval details
- PMA number
- P890054
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THE BOSTON TM CLEANER II
- Generic name
- Accessories, soft lens products
- Applicant
- Polymer Technology Corp.
- Date received
- 1994-07-22
- Decision date
- 1994-08-15
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LPN
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Wilmington, MA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K011945) | Polymer Technology Corp. | 2001-09-12 |
| BAUSCH & LOMB WETTING AND SOAKING SOLUTION (K980133) | Polymer Technology Corp. | 1998-03-11 |
| BOSTON ADVANCE CLEANER (K974466) | Polymer Technology Corp. | 1998-02-19 |
| BOSTON LIQUID ENZYMATIC CLEANER (K973217) | Polymer Technology Corp. | 1997-11-24 |
| BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS (K970698) | Polymer Technology Corp. | 1997-05-06 |
| BOSTON CONTACT LENS CASE (K951552) | Polymer Technology Corp. | 1995-06-26 |
| BOSTON(R) 7 - 30(ENFLUFOCON A) (K943177) | Polymer Technology Corp. | 1994-08-25 |
| BOSTON VII (K942365) | Polymer Technology Corp. | 1994-06-23 |