The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Sterile Suture Boots.
| Device ID | K834135 |
| 510k Number | K834135 |
| Device Name: | STERILE SUTURE BOOTS |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | DEVON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-01 |
| Decision Date | 1984-04-27 |