510(k) K875119
K875119 is an FDA 510(k) premarket notification submitted by Advanced Diagnostic Medical Systems, Inc. for the device "BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE". The FDA issued a decision of Substantially Equivalent on March 2, 1988. The device falls under product code FCI (Punch, Biopsy), a Class II device regulated under 21 CFR 876.1075. Advanced Diagnostic Medical Systems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1988
- Date Received
- December 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Biopsy
- Device Class
- Class II
- Regulation Number
- 876.1075
- Review Panel
- GU
- Submission Type