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 |