The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Surgical Stainless Steel Suture, Stainless Steel Suture.
| Device ID | K170767 |
| 510k Number | K170767 |
| Device Name: | Surgical Stainless Steel Suture, Stainless Steel Suture |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | Ethicon, Inc. P.O. Box 151 Route 22 West Somerville, NJ 08876 -0151 |
| Contact | Hrishikesh Khatav |
| Correspondent | Hrishikesh Khatav Ethicon, Inc. P.O. Box 151 Route 22 West Somerville, NJ 08876 -0151 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-14 |
| Decision Date | 2017-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031238903 | K170767 | 000 |
| 30705031134250 | K170767 | 000 |
| 30705031238736 | K170767 | 000 |
| 30705031238743 | K170767 | 000 |
| 30705031203352 | K170767 | 000 |
| 30705031027064 | K170767 | 000 |