BOSTON ADVANCE CLEANER
FDA 510(k) clearance K974466 · decided 1998-02-19
Clearance details
- K-number
- K974466
- Device name
- BOSTON ADVANCE CLEANER
- Applicant
- Polymer Technology Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-26
- Decision date
- 1998-02-19
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- MRC
- Device class
- 2
- Regulation number
- 886.5918
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, 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 |
|---|---|---|
| BOSTON LENS(R) CLEANER (P820069/S013) | Polymer Technology Corp. | 1994-08-15 |
| THE BOSTON TM CLEANER II (P890054/S001) | Polymer Technology Corp. | 1994-08-15 |
| BOSTON LENS II & IV (P820065/S082) | Polymer Technology Corp. | 1994-02-16 |
| BOSTON LENS II & IV (P820065/S080) | Polymer Technology Corp. | 1993-09-07 |
| BOSTON LENS II & IV (P820065/S081) | Polymer Technology Corp. | 1993-09-07 |
| BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION (P820065/S079) | Polymer Technology Corp. | 1992-08-06 |
| BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION (P820065/S078) | Polymer Technology Corp. | 1992-04-06 |
| BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS (P820065/S077) | Polymer Technology Corp. | 1992-02-20 |