The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Quadro Switch.
Device ID | K021776 |
510k Number | K021776 |
Device Name: | KSEA QUADRO SWITCH |
Classification | Endoscopic Irrigation/suction System |
Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | James A Lee |
Correspondent | James A Lee KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | OCX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-29 |
Decision Date | 2002-08-15 |
Summary: | summary |