The following data is part of a premarket notification filed by Visionary Medical Supplies, Inc. with the FDA for Sutrasilk Silk Suture.
| Device ID | K994177 |
| 510k Number | K994177 |
| Device Name: | SUTRASILK SILK SUTURE |
| Classification | Suture, Nonabsorbable, Silk |
| 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 | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| 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 |
|---|---|---|
| M583VS840823 | K994177 | 000 |
| M583VS840813 | K994177 | 000 |
| M583S840823 | K994177 | 000 |
| M583S74092TP3 | K994177 | 000 |
| M583S740923 | K994177 | 000 |
| M583S6401123 | K994177 | 000 |
| M583S440171C3 | K994177 | 000 |