510(k) K903174
K903174 is an FDA 510(k) premarket notification submitted by Advance Suture, Inc. for the device "ADVANCE SUTURE ABSORBABLE GUT SUTURE". The FDA issued a decision of Substantially Equivalent on July 10, 1991. The device falls under product code GAE (Snare, Surgical), a Class I device regulated under 21 CFR 878.4800. Advance Suture, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1991
- Date Received
- July 18, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Snare, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type