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 |