KIMGUARD ONE-STEP Sterilization Wrap
FDA 510(k) clearance K143053 · decided 2015-04-03
Clearance details
- K-number
- K143053
- Device name
- KIMGUARD ONE-STEP Sterilization Wrap
- Applicant
- Kimberly-Clark Health Care
- Decision
- Substantially Equivalent
- Date received
- 2014-10-23
- Decision date
- 2015-04-03
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Roswell, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.