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 |