510(k) K915801
K915801 is an FDA 510(k) premarket notification submitted by Uni-Quatro Industries Canada, Inc. for the device "BIP-COAX-SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 11, 1994. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Uni-Quatro Industries Canada, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 1994
- Date Received
- Dec 24, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Biopsy Needle
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type
- 510(k)