The following data is part of a premarket notification filed by Pointe Conception Medical, Inc with the FDA for Endohub- 1.0 Endoscopic Video Camera System With Video Capture.
| Device ID | K071756 |
| 510k Number | K071756 |
| Device Name: | ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | POINTE CONCEPTION MEDICAL, INC 121 E. MASON STREET Santa Barbara, CA 93101 |
| Contact | William C Haack |
| Correspondent | William C Haack POINTE CONCEPTION MEDICAL, INC 121 E. MASON STREET Santa Barbara, CA 93101 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-28 |
| Decision Date | 2007-08-15 |
| Summary: | summary |