The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Ksea Plastic Trocars.
Device ID | K974366 |
510k Number | K974366 |
Device Name: | KSEA PLASTIC TROCARS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Contact | Kevin Kennan |
Correspondent | Kevin Kennan KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-20 |
Decision Date | 1998-01-08 |
Summary: | summary |