The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Sentry Expanding Introducer Sheath (eis).
| Device ID | K000545 |
| 510k Number | K000545 |
| Device Name: | SENTRY EXPANDING INTRODUCER SHEATH (EIS) |
| 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 | 2000-02-18 |
| Decision Date | 2000-05-02 |