The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Suture Clinch.
| Device ID | K992852 |
| 510k Number | K992852 |
| Device Name: | SUTURE CLINCH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills, CA 92653 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-24 |
| Decision Date | 1999-11-22 |
| Summary: | summary |