The following data is part of a premarket notification filed by Karl Storz Endoskop Gmbh with the FDA for Trocars,cannulae, Sheaths.
| Device ID | K943816 |
| 510k Number | K943816 |
| Device Name: | TROCARS,CANNULAE, SHEATHS |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | Marika Anderson |
| Correspondent | Marika Anderson KARL STORZ ENDOSKOP GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1994-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048551194621 | K943816 | 000 |
| 04048551010525 | K943816 | 000 |
| 04048551010518 | K943816 | 000 |
| 04048551010501 | K943816 | 000 |
| 04048551010495 | K943816 | 000 |