The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Clearvision Lens Irrigation System.
Device ID | K013838 |
510k Number | K013838 |
Device Name: | KSEA CLEARVISION LENS IRRIGATION SYSTEM |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | James A Lee |
Correspondent | James A Lee KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-19 |
Decision Date | 2002-01-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04048551419991 | K013838 | 000 |
04048551419984 | K013838 | 000 |
04048551419908 | K013838 | 000 |