ENDOSCOPIC CATHETER— 510(k) K953967
Substantially EquivalentAct Medical, Inc.
FDA 510(k) clearance K953967 for ENDOSCOPIC CATHETER, Substantially Equivalent on 1996-01-22. Applicant: Act Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Act Medical, Inc.
- 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
- Waltham, MA, US
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