INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
FDA 510(k) clearance K910610 · decided 1991-07-09
Clearance details
- K-number
- K910610
- Device name
- INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-12
- Decision date
- 1991-07-09
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- JEQ
- Device class
- 1
- Regulation number
- 872.6865
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tucker, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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| enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059) | Bausch & Lomb, Inc. | 2025-05-30 |
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