The following data is part of a premarket notification filed by Innovative Surgical Technology, Inc. with the FDA for Los Alamos Retractable Knife.
| Device ID | K923170 |
| 510k Number | K923170 |
| Device Name: | LOS ALAMOS RETRACTABLE KNIFE |
| Classification | Blade, Scalpel |
| Applicant | INNOVATIVE SURGICAL TECHNOLOGY, INC. 901 18TH ST. P.O. BOX 148 Los Alamos, NM 87544 |
| Contact | Michael Jackson |
| Correspondent | Michael Jackson INNOVATIVE SURGICAL TECHNOLOGY, INC. 901 18TH ST. P.O. BOX 148 Los Alamos, NM 87544 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1993-02-18 |