PRECISE IMPRESSION KIT— 510(k) K970952
Substantially EquivalentStarkey Laboratories, Inc.
FDA 510(k) clearance K970952 for PRECISE IMPRESSION KIT, Substantially Equivalent on 1997-05-02. Applicant: Starkey Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Starkey Laboratories, Inc.
- Product code
- Code ESD
- Device class
- Class 1
- Regulation
- 21 CFR 874.3300
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code ESD
view allMore clearances from Starkey Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.