The following data is part of a premarket notification filed by Ackermann Instrumente Gmbh with the FDA for Ackermann Surgical Instruments.
Device ID | K974382 |
510k Number | K974382 |
Device Name: | ACKERMANN SURGICAL INSTRUMENTS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | ACKERMANN INSTRUMENTE GMBH 3407 BAY AVE. Chico, CA 95973 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson ACKERMANN INSTRUMENTE GMBH 3407 BAY AVE. Chico, CA 95973 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-21 |
Decision Date | 1998-04-21 |
Summary: | summary |