INFANT CANNULA
FDA 510(k) clearance K873012 · decided 1988-05-02
Clearance details
- K-number
- K873012
- Device name
- INFANT CANNULA
- Applicant
- Gresco International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-04
- Decision date
- 1988-05-02
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- DQR
- Device class
- 2
- Regulation number
- 870.1300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.