The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. D/b/a Estech with the FDA for Estech Hawkeye Introducer Systems.
| Device ID | K091350 |
| 510k Number | K091350 |
| Device Name: | ESTECH HAWKEYE INTRODUCER SYSTEMS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH 2603 CAMINO RAMON SUITE 100 San Ramon, CA 94583 |
| Contact | Tamer Ibrahim |
| Correspondent | Tamer Ibrahim ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH 2603 CAMINO RAMON SUITE 100 San Ramon, CA 94583 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-07 |
| Decision Date | 2009-09-15 |
| Summary: | summary |