The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Karl Storz Catheters, Mandrin, Plugs, Connector.
| Device ID | K951995 |
| 510k Number | K951995 |
| Device Name: | KARL STORZ CATHETERS, MANDRIN, PLUGS, CONNECTOR |
| Classification | Accessories, Catheter, G-u |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Judith K Murphy |
| Correspondent | Judith K Murphy KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-28 |
| Decision Date | 1995-05-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551086025 | K951995 | 000 |