The following data is part of a premarket notification filed by Visionary Medical Supplies, Inc. with the FDA for Sutrazorb.
| Device ID | K102592 |
| 510k Number | K102592 |
| Device Name: | SUTRAZORB |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | VISIONARY MEDICAL SUPPLIES, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring VISIONARY MEDICAL SUPPLIES, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-09 |
| Decision Date | 2011-02-03 |
| Summary: | summary |