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 |