The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Disposable Laparoscopic Swab With Reusable Handle.
| Device ID | K943970 |
| 510k Number | K943970 |
| Device Name: | DISPOSABLE LAPAROSCOPIC SWAB WITH REUSABLE HANDLE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-15 |
| Decision Date | 1994-09-06 |