MEDCOMP ASH SPLIT— 510(k) K011576
Substantially EquivalentMedical Components, Inc.
FDA 510(k) clearance K011576 for MEDCOMP ASH SPLIT, Substantially Equivalent on 2001-06-21. Applicant: Medical Components, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Components, Inc.
- Product code
- Code NFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Harleysville, PA, US
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