The following data is part of a premarket notification filed by Owens Precision Systems, Inc. with the FDA for Laparoscopy Set.
| Device ID | K924485 |
| 510k Number | K924485 |
| Device Name: | LAPAROSCOPY SET |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | OWENS PRECISION SYSTEMS, INC. 7815 SOUTH 6TH ST. Oak Creek, WI 53154 |
| Contact | Lanis P Pholsgrof |
| Correspondent | Lanis P Pholsgrof OWENS PRECISION SYSTEMS, 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 | 1992-09-03 |
| Decision Date | 1994-03-09 |