510(k) K801652
K801652 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "TOTAL PARENTERAL NUTRITION SET BAG". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1980
- Date Received
- July 18, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type