The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Pds(tm) Barbed Sutures.
| Device ID | K113004 |
| 510k Number | K113004 |
| Device Name: | PDS(TM) BARBED SUTURES |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Peter Cecchini |
| Correspondent | Peter Cecchini ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-07 |
| Decision Date | 2011-12-20 |
| Summary: | summary |