L-CATH PEEL AWAY SYSTEM CATHETER
FDA 510(k) clearance K920755 · decided 1993-06-07
Clearance details
- K-number
- K920755
- Device name
- L-CATH PEEL AWAY SYSTEM CATHETER
- Applicant
- Luther Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-19
- Decision date
- 1993-06-07
- Days to decision
- 474 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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