Lifecell Recovery Container
FDA 510(k) K893787 · Baxter Healthcare Corp
510(k) numberK893787
Submission
- Device name
- Lifecell Recovery Container
- Applicant
- Baxter Healthcare Corp
Round Lake, IL, US - Received
- May 22, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KJF – System, Suspension, Cell Culture
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.2240
- Specialty
- Hematology
Other 510(k)s with product code KJF
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Questions and answers
When was Lifecell Recovery Container cleared by the FDA?
Lifecell Recovery Container (K893787) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 32 days after the submission was received.
What is the product code of K893787?
The FDA product code is KJF – System, Suspension, Cell Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.