The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Pressure Cuff For Use With The Ksea Hydromat Pump.
| Device ID | K951105 |
| 510k Number | K951105 |
| Device Name: | KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 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 | 1995-03-10 |
| Decision Date | 1995-10-20 |