510(k) K873109
K873109 is an FDA 510(k) premarket notification submitted by Life-Tech Intl., Inc. for the device "MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET". The FDA issued a decision of Substantially Equivalent on August 28, 1987. The device falls under product code OJA (Intravenous Extension Tubing Set), a Class II device regulated under 21 CFR 880.5440. Life-Tech Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1987
- Date Received
- August 7, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intravenous Extension Tubing Set
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.