LIFESTYLE BREAK THRU (POLYMACON)
FDA 510(k) clearance K965012 · decided 1997-03-11
Clearance details
- K-number
- K965012
- Device name
- LIFESTYLE BREAK THRU (POLYMACON)
- Applicant
- The Lifestyle Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-16
- Decision date
- 1997-03-11
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Morganville, NJ, 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 |
|---|---|---|
| GAS PERMEABLE CONTACT LENSES (P840055/S032) | The Lifestyle Co., Inc. | 1994-02-04 |
| RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B) (P840055/S028) | The Lifestyle Co., Inc. | 1994-01-31 |
| RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B) (P840055/S030) | The Lifestyle Co., Inc. | 1993-07-12 |
| RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B) (P840055/S031) | The Lifestyle Co., Inc. | 1993-05-27 |
| RIGID GAS PERMEABLE CONTACT LENSES (P900001/S009) | The Lifestyle Co., Inc. | 1993-05-27 |
| RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B) (P840055/S029) | The Lifestyle Co., Inc. | 1992-12-04 |
| RIGID GAS PERMEABLE CONTACT LENSES (P900001/S007) | The Lifestyle Co., Inc. | 1992-12-04 |
| RIGID GAS PERMEABLE CONTACT LENSES (P900001/S008) | The Lifestyle Co., Inc. | 1992-12-04 |