510(k) K760899
K760899 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "STERILE DISPOSABLE COTTON PLUGGED SER.". The FDA issued a decision of Substantially Equivalent on November 9, 1976. The device falls under product code GJW (Pipette, Pasteur), a Class I device regulated under 21 CFR 864.6160. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1976
- Date Received
- October 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pipette, Pasteur
- Device Class
- Class I
- Regulation Number
- 864.6160
- Review Panel
- HE
- Submission Type