The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Adult And Pediatric Viscous Fluid Injection Sets.
| Device ID | K950976 |
| 510k Number | K950976 |
| Device Name: | KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-01 |
| Decision Date | 1995-03-21 |