The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Hysteroscopy Sheath Set.
| Device ID | K903146 |
| 510k Number | K903146 |
| Device Name: | HYSTEROSCOPY SHEATH SET |
| Classification | Hysteroscope (and Accessories) |
| Applicant | COOK, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Michelle Young |
| Correspondent | Michelle Young COOK, INC. 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-18 |
| Decision Date | 1990-10-12 |