SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM— 510(k) K910769
Substantially EquivalentSurgitek Medical Engineering Corp.
FDA 510(k) clearance K910769 for SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM, Substantially Equivalent on 1991-06-25. Applicant: Surgitek Medical Engineering Corp.. Device class: 2.
Clearance details
- Applicant
- Surgitek Medical Engineering Corp.
- Product code
- Code ODD
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Racine, WI, US
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