BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
FDA 510(k) clearance K032568 · decided 2004-04-29
Clearance details
- K-number
- K032568
- Device name
- BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193
- Applicant
- Med Textile, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-08-20
- Decision date
- 2004-04-29
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Colonial Heights, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.