MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET
FDA 510(k) clearance K873109 · decided 1987-08-28
Clearance details
- K-number
- K873109
- Device name
- MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET
- Applicant
- Life-Tech Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-07
- Decision date
- 1987-08-28
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- OJA
- 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.