The following data is part of a premarket notification filed by Visionary Medical Supplies, Inc. with the FDA for Sutralene Polypropylene Sutures.
| Device ID | K070243 |
| 510k Number | K070243 |
| Device Name: | SUTRALENE POLYPROPYLENE SUTURES |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-25 |
| Decision Date | 2007-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M583P990623 | K070243 | 000 |
| M583P90090623 | K070243 | 000 |
| M583P9006223 | K070243 | 000 |
| M583P900623 | K070243 | 000 |
| M583P90060623 | K070243 | 000 |
| M583P540151RC3 | K070243 | 000 |
| M583P109062TP3 | K070243 | 000 |
| M583P1000623 | K070243 | 000 |