TRANDUCER PROTECTOR— 510(k) K851428
Substantially EquivalentGalvin Industries, Inc.
FDA 510(k) clearance K851428 for TRANDUCER PROTECTOR, Substantially Equivalent on 1985-05-21. Applicant: Galvin Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Galvin Industries, Inc.
- Product code
- Code FIB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.