The following data is part of a premarket notification filed by M/s. Meril Endo Surgery Private Limited with the FDA for Megasorb, Mitsu, Mitsu Fst, Filaxyn, Filapron.
| Device ID | K150717 |
| 510k Number | K150717 |
| Device Name: | Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | M/s. Meril Endo Surgery Private Limited Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2 Muktanand Marg Chala, Vapi, IN |
| Contact | Umesh Sharma |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-19 |
| Decision Date | 2015-10-14 |