Model CC-72 Cavernosometry/Cavernosography Set
FDA 510(k) K873109 · Life-Tech Intl., Inc.
510(k) numberK873109
Submission
- Device name
- Model CC-72 Cavernosometry/Cavernosography Set
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- August 7, 1987
- Decision date
- August 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- OJA – Intravenous Extension Tubing Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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.
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Questions and answers
When was Model CC-72 Cavernosometry/Cavernosography Set cleared by the FDA?
Model CC-72 Cavernosometry/Cavernosography Set (K873109) received a 510(k) decision of Substantially Equivalent on August 28, 1987, 21 days after the submission was received.
What is the product code of K873109?
The FDA product code is OJA – Intravenous Extension Tubing Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.