The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Endoscopic Cold Knife Blades.
| Device ID | K934730 |
| 510k Number | K934730 |
| Device Name: | KARL STORZ ENDOSCOPIC COLD KNIFE BLADES |
| Classification | Urethrotome |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | EZO |
| CFR Regulation Number | 876.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-01 |
| Decision Date | 1994-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551273869 | K934730 | 000 |