The following data is part of a premarket notification filed by Rk Manufacturing Corporation with the FDA for Rondek Pga Suture (beige Or Violet).
| Device ID | K180625 |
| 510k Number | K180625 |
| Device Name: | Rondek PGA Suture (Beige Or Violet) |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | RK Manufacturing Corporation 34 Executive Drive Danbury, CT 06810 |
| Contact | Joshua Hubbard |
| Correspondent | John Gillespie Clover Medical, LLC 79 Haven St. Dover, MA 02030 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-09 |
| Decision Date | 2018-05-10 |
| Summary: | summary |