The following data is part of a premarket notification filed by Nobles Medical Technologies Ii, Inc. with the FDA for Srm-stitch 8f Srm-stitch 8f With Guidewire.
| Device ID | K113763 |
| 510k Number | K113763 |
| Device Name: | SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | NOBLES MEDICAL TECHNOLOGIES II, INC. 17080 Newhope St Fountain Valley, CA 92708 |
| Contact | Maria Hategan |
| Correspondent | Maria Hategan NOBLES MEDICAL TECHNOLOGIES II, INC. 17080 Newhope St Fountain Valley, CA 92708 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-21 |
| Decision Date | 2012-03-16 |
| Summary: | summary |