The following data is part of a premarket notification filed by Laurus Medical Corp. with the FDA for Disposable Suture Placement System.
| Device ID | K932553 |
| 510k Number | K932553 |
| Device Name: | DISPOSABLE SUTURE PLACEMENT SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LAURUS MEDICAL CORP. 30 HUGHES SUITE 202 Irvine, CA 92718 |
| Contact | Norman Gordon |
| Correspondent | Norman Gordon LAURUS MEDICAL CORP. 30 HUGHES SUITE 202 Irvine, CA 92718 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-26 |
| Decision Date | 1994-05-12 |