KARL STORZ BOUGIES AND DILATORS— 510(k) K950125
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K950125 for KARL STORZ BOUGIES AND DILATORS, Substantially Equivalent on 1995-02-07. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 1.
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code FAX
- Device class
- Class 1
- Regulation
- 21 CFR 876.5520
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Recent devices under product code FAX
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