The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Laparoscopic Balloon Retractor.
| Device ID | K914203 |
| 510k Number | K914203 |
| Device Name: | LAPAROSCOPIC BALLOON RETRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ORIGIN MEDSYSTEMS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Contact | Albert K Chin |
| Correspondent | Albert K Chin ORIGIN MEDSYSTEMS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-19 |
| Decision Date | 1991-10-09 |