510(k) K811771
K811771 is an FDA 510(k) premarket notification submitted by Lab Industries, Inc. for the device "A.D.T. REUSABLE BONE MARROW NEEDLE". The FDA issued a decision of Substantially Equivalent on Jul 10, 1981. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Lab Industries, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 1981
- Date Received
- Jun 22, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Aspiration And Injection, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type
- 510(k) Exempt