510(k) K781364
K781364 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "PINT BOTTLE WELL". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1978
- Date Received
- August 7, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dispenser, Liquid Medication
- Device Class
- Class I
- Regulation Number
- 880.6430
- Review Panel
- HO
- Submission Type