The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Ksea Chardonnes Morcellation Knife.
Device ID | K000212 |
510k Number | K000212 |
Device Name: | KSEA CHARDONNES MORCELLATION KNIFE |
Classification | Instrument, Manual, General Obstetric-gynecologic |
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 | KOH |
CFR Regulation Number | 884.4520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-24 |
Decision Date | 2000-04-21 |