The following data is part of a premarket notification filed by Suturtek Incorporated with the FDA for Suturtek Surgical Steel Suture, Models Sc-s13, Sc-s14, Sc-s15, Sc-s16, Sc-s17.
| Device ID | K063603 |
| 510k Number | K063603 |
| Device Name: | SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | SUTURTEK INCORPORATED 6 BROOKSIDE CIRCLE Acton, MA 01720 |
| Contact | Art Rankis |
| Correspondent | Art Rankis SUTURTEK INCORPORATED 6 BROOKSIDE CIRCLE Acton, MA 01720 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-03 |
| Decision Date | 2007-02-07 |
| Summary: | summary |