The following data is part of a premarket notification filed by Laurus Medical Group with the FDA for Suture Applicator.
| Device ID | K964672 |
| 510k Number | K964672 |
| Device Name: | SUTURE APPLICATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LAURUS MEDICAL GROUP 10 CHRYSLER SUITE B Irvine, CA 92618 |
| Contact | Richard A Basler |
| Correspondent | Richard A Basler LAURUS MEDICAL GROUP 10 CHRYSLER SUITE B Irvine, CA 92618 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-21 |
| Decision Date | 1997-02-07 |