The following data is part of a premarket notification filed by Owens Industries, Inc. with the FDA for Owens Trocar.
| Device ID | K932796 |
| 510k Number | K932796 |
| Device Name: | OWENS TROCAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OWENS INDUSTRIES, INC. 7815 S. 6TH ST. Oak Creek, WI 53154 |
| Contact | Terrence R Shore |
| Correspondent | Terrence R Shore OWENS INDUSTRIES, INC. 7815 S. 6TH ST. Oak Creek, WI 53154 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1994-02-02 |