The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Ethicon Securestrap 5mm Absorbable Strap Fixation Device, Model Strap25.
Device ID | K093845 |
510k Number | K093845 |
Device Name: | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 |
Classification | Staple, Implantable |
Applicant | ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
Contact | Joseph Kiceina |
Correspondent | Joseph Kiceina ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-15 |
Decision Date | 2010-04-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30705031132973 | K093845 | 000 |
30705031132980 | K093845 | 000 |
10705031470552 | K093845 | 000 |
10705031470576 | K093845 | 000 |