The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origin Preperitoneal Dissection Balloon System (pdbs)--extra.
| Device ID | K946002 |
| 510k Number | K946002 |
| Device Name: | ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ORIGIN MEDSYSTEMS, INC. 130 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Sandra V Diggs |
| Correspondent | Sandra V Diggs ORIGIN MEDSYSTEMS, INC. 130 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-22 |
| Decision Date | 1995-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521067940 | K946002 | 000 |