ELECTROCAUTERY SYSTEM MODEL 1980
FDA 510(k) clearance K933079 · decided 1994-02-22
Clearance details
- K-number
- K933079
- Device name
- ELECTROCAUTERY SYSTEM MODEL 1980
- Applicant
- Pmt Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-23
- Decision date
- 1994-02-22
- Days to decision
- 244 days
- Clearance type
- Traditional
- Product code
- HQP
- Device class
- 2
- Regulation number
- 886.4115
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chanhassen, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.