The following data is part of a premarket notification filed by Visionary Medical Supplies, Inc. with the FDA for Sutralon Nylon Sutures.
| Device ID | K994176 |
| 510k Number | K994176 |
| Device Name: | SUTRALON NYLON SUTURES |
| Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
| Applicant | VISIONARY MEDICAL SUPPLIES, INC. 4740 CONNECTICUT AVE. N.W. SUITE 708 Washington, DC 20008 |
| Contact | Jonathan Green |
| Correspondent | Jonathan Green VISIONARY MEDICAL SUPPLIES, INC. 4740 CONNECTICUT AVE. N.W. SUITE 708 Washington, DC 20008 |
| Product Code | GAR |
| CFR Regulation Number | 878.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-10 |
| Decision Date | 2000-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M583N960623 | K994176 | 000 |
| M583N1040623 | K994176 | 000 |
| M583N1040813 | K994176 | 000 |
| M583N1040823 | K994176 | 000 |
| M583N1060613 | K994176 | 000 |
| M583N1060623 | K994176 | 000 |
| M583N6401123 | K994176 | 000 |
| M583N74092TP3 | K994176 | 000 |
| M583N840823 | K994176 | 000 |
| M583N940613 | K994176 | 000 |
| M583N940623 | K994176 | 000 |
| M583N940813 | K994176 | 000 |
| M583N940823 | K994176 | 000 |
| M583N960613 | K994176 | 000 |
| M583N1040613 | K994176 | 000 |