The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Duo Balloon System (dbs) 2 [10 And 12 Mm Sizes].
| Device ID | K954174 |
| 510k Number | K954174 |
| Device Name: | DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES] |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Anthony D Durso |
| Correspondent | Anthony D 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 | 1995-09-05 |
| Decision Date | 1995-11-09 |