The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Model 203020 20 Equimat.
| Device ID | K971982 |
| 510k Number | K971982 |
| Device Name: | KARL STORZ MODEL 203020 20 EQUIMAT |
| Classification | System, Irrigation, Urological |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin A Kennan |
| Correspondent | Kevin A Kennan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-08-12 |
| Summary: | summary |