3MM DISPOSABLE SPECULA— 510(k) K891589
Substantially EquivalentSemantodontics, Inc.
FDA 510(k) clearance K891589 for 3MM DISPOSABLE SPECULA, Substantially Equivalent on 1989-04-18. Applicant: Semantodontics, Inc.. Device class: 1.
Clearance details
- Applicant
- Semantodontics, Inc.
- Product code
- Code FXG
- Device class
- Class 1
- Regulation
- 21 CFR 878.1800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.