The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Dci Endoscope.
| Device ID | K983363 |
| 510k Number | K983363 |
| Device Name: | DCI ENDOSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Kevin Kennan |
| Correspondent | Kevin Kennan KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-24 |
| Decision Date | 1998-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551324714 | K983363 | 000 |
| 04048551006214 | K983363 | 000 |
| 04048551006207 | K983363 | 000 |