510(k) K983744
K983744 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "MCAS (MODULAR CLIP APPLIER SYSTEM)". The FDA issued a decision of Substantially Equivalent on January 21, 1999. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250. Applied Medical Resources has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1999
- Date Received
- October 23, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Vascular
- Device Class
- Class II
- Regulation Number
- 870.3250
- Review Panel
- CV
- Submission Type