The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Co2 Hydromat Pump For Irrigation, Model #26310020.
| Device ID | K932276 |
| 510k Number | K932276 |
| Device Name: | CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020 |
| 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 | 1993-05-12 |
| Decision Date | 1995-02-28 |