510(k) K173779
K173779 is an FDA 510(k) premarket notification submitted by Sm Eng Co., Ltd. for the device "REXMONO, PDREX". The FDA issued a decision of Substantially Equivalent on March 12, 2018. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Sm Eng Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2018
- Date Received
- December 12, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type