MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
FDA 510(k) clearance K080878 · decided 2008-07-17
Clearance details
- K-number
- K080878
- Device name
- MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
- Applicant
- Medical Technologies of Georgia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-03-31
- Decision date
- 2008-07-17
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Covington, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.