KSEA CALCUSPLIT— 510(k) K981233
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K981233 for KSEA CALCUSPLIT, Substantially Equivalent on 1998-06-15. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code FFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code FFK
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