510(k) K780167
K780167 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "CATH KIT, URINE SPECIMEN". The FDA issued a decision of Substantially Equivalent on February 21, 1978. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1978
- Date Received
- February 2, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Specimen, Sterile
- Device Class
- Class I
- Regulation Number
- 864.3250
- Review Panel
- HO
- Submission Type