The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Hydromat Trumpet Valve And Tubing Set For Laparoscopic Suction And Irrigation.
| Device ID | K940462 |
| 510k Number | K940462 |
| Device Name: | HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Paul L Sumner |
| Correspondent | Paul L Sumner KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-05-10 |