AMNIOINFUSION CATHETER— 510(k) K862182
Substantially EquivalentMichael Reese Hospital and Medical Center
FDA 510(k) clearance K862182 for AMNIOINFUSION CATHETER, Substantially Equivalent on 1986-08-25. Applicant: Michael Reese Hospital and Medical Center. Device class: 2.
Clearance details
- Applicant
- Michael Reese Hospital and Medical Center
- Product code
- Code KXO
- Device class
- Class 2
- Regulation
- 21 CFR 884.2700
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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More clearances from Michael Reese Hospital and Medical Center
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