MODEL DMC-75 MINI-CATHETER SET
FDA 510(k) clearance K874307 · decided 1988-01-29
Clearance details
- K-number
- K874307
- Device name
- MODEL DMC-75 MINI-CATHETER SET
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-10-20
- Decision date
- 1988-01-29
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.