510(k) K803212
K803212 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BAUER & BLACK ARM SLING W/DETACH. POUCH". The FDA issued a decision of Substantially Equivalent on January 8, 1981. The device falls under product code ILI (Sling, Arm), a Class I device regulated under 21 CFR 890.3640. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1981
- Date Received
- December 17, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sling, Arm
- Device Class
- Class I
- Regulation Number
- 890.3640
- Review Panel
- PM
- Submission Type