The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Laparoscopic Access Sheath Set.
| Device ID | K897064 |
| 510k Number | K897064 |
| Device Name: | LAPAROSCOPIC ACCESS SHEATH SET |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-20 |
| Decision Date | 1990-02-06 |