LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP
FDA 510(k) clearance K945761 · decided 1995-04-10
Clearance details
- K-number
- K945761
- Device name
- LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP
- Applicant
- Aaron Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1994-11-09
- Decision date
- 1995-04-10
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- HQP
- Device class
- 2
- Regulation number
- 886.4115
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Petersburg, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.