510(k) K180625
K180625 is an FDA 510(k) premarket notification submitted by Rk Manufacturing Corporation for the device "Rondek PGA Suture (Beige or Violet)". The FDA issued a decision of Substantially Equivalent on May 10, 2018. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2018
- Date Received
- Mar 9, 2018
- 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
- 510(k)