CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH— 510(k) K914316
Substantially Equivalent for Some IndicationsMedi-Flex Hospital Products, Inc.
FDA 510(k) clearance K914316 for CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH, Substantially Equivalent for Some Indications on 1991-12-24. Applicant: Medi-Flex Hospital Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Medi-Flex Hospital Products, Inc.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
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