COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
FDA 510(k) clearance K854375 · decided 1985-12-27
Clearance details
- K-number
- K854375
- Device name
- COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-30
- Decision date
- 1985-12-27
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.