D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
FDA 510(k) clearance K012821 · decided 2001-10-22
Clearance details
- K-number
- K012821
- Device name
- D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
- Applicant
- Dutch Ophthalmic USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-23
- Decision date
- 2001-10-22
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- HRN
- Device class
- 2
- Regulation number
- 886.4170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Kingston, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.