510(k) K901995
K901995 is an FDA 510(k) premarket notification submitted by Mill-Rose Laboratory for the device "PLEURA BIOPSY DEVICE". The FDA issued a decision of Substantially Equivalent on July 10, 1990. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. Mill-Rose Laboratory has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1990
- Date Received
- May 2, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type