GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM— 510(k) K090557
Substantially EquivalentGiven Imaging , Ltd.
FDA 510(k) clearance K090557 for GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM, Substantially Equivalent on 2009-09-28. Applicant: Given Imaging , Ltd.. Device class: 2.
Clearance details
- Applicant
- Given Imaging , Ltd.
- Product code
- Code NSI
- Device class
- Class 2
- Regulation
- 21 CFR 876.1300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yoqneaam, IL
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