510(k) K842912
K842912 is an FDA 510(k) premarket notification submitted by Vlm Surgical, Inc. for the device "THE SUTURER". The FDA issued a decision of Substantially Equivalent on August 15, 1984. Vlm Surgical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 1984
- Date Received
- July 25, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No