The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Suctyion/irrigation Tubes, Cannulae.
Device ID | K945237 |
510k Number | K945237 |
Device Name: | KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE |
Classification | Esophagoscope (flexible Or Rigid) |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Betty M Johnson |
Correspondent | Betty M Johnson KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | EOX |
CFR Regulation Number | 874.4710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-27 |
Decision Date | 1994-12-21 |