The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Endoscopic High Frequency Monopolar Cord.
| Device ID | K934985 |
| 510k Number | K934985 |
| Device Name: | ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Contact | Robert R Giorgini |
| Correspondent | Robert R Giorgini KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-18 |
| Decision Date | 1994-02-17 |