The following data is part of a premarket notification filed by Owens Industries, Inc. with the FDA for Owens Endoscopic Instruments And Accessories.
| Device ID | K926596 |
| 510k Number | K926596 |
| Device Name: | OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OWENS INDUSTRIES, INC. 7815 SOUTH 6TH ST. Oak Creek, WI 53154 |
| Contact | Terrence R Shore |
| Correspondent | Terrence R Shore OWENS INDUSTRIES, INC. 7815 SOUTH 6TH ST. Oak Creek, WI 53154 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-09 |
| Decision Date | 1994-06-10 |