The following data is part of a premarket notification filed by Nobles Medical Technologies Ii, Inc. with the FDA for Noblestitch El.
| Device ID | K162617 |
| 510k Number | K162617 |
| Device Name: | NobleStitch EL |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | NOBLES MEDICAL TECHNOLOGIES II, INC. 17074 NEWHOPE ST. Fountain Valley, CA 92708 |
| Contact | Faye Dunn |
| Correspondent | Jason Lyon NOBLES MEDICAL TECHNOLOGIES II, INC. 17074 NEWHOPE ST. Fountain Valley, CA 92708 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2017-04-06 |
| Summary: | summary |