The following data is part of a premarket notification filed by Onux Medical, Inc. with the FDA for Manual Touche System.
| Device ID | K022777 |
| 510k Number | K022777 |
| Device Name: | MANUAL TOUCHE SYSTEM |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | ONUX MEDICAL, INC. 5 MERRILL DR. Hampton, NH 03842 |
| Contact | Ruthann Depietro |
| Correspondent | Ruthann Depietro ONUX MEDICAL, INC. 5 MERRILL DR. Hampton, NH 03842 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-21 |
| Decision Date | 2002-11-19 |
| Summary: | summary |