The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Extrahand Balloon Retractor.
| Device ID | K962005 |
| 510k Number | K962005 |
| Device Name: | EXTRAHAND BALLOON RETRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Anthony Durso |
| Correspondent | Anthony Durso ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-22 |
| Decision Date | 1996-08-12 |