The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Hydromat 263110-20 Pressure Chambers And Accessories.
| Device ID | K972488 |
| 510k Number | K972488 |
| Device Name: | KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marlena A Piercy |
| Correspondent | Marlena A Piercy KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-02 |
| Decision Date | 1998-01-22 |
| Summary: | summary |