The following data is part of a premarket notification filed by Atrion Medical Products, Inc. with the FDA for Atrion Medical Autogenous Tissue Collector.
| Device ID | K971100 |
| 510k Number | K971100 |
| Device Name: | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR |
| Classification | Unit, Operative Dental |
| Applicant | ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab, AL 35016 |
| Contact | Dan Clarke |
| Correspondent | Dan Clarke ATRION MEDICAL PRODUCTS, INC. 1426 CURT FRANCIS RD. Arab, AL 35016 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-26 |
| Decision Date | 1997-05-23 |
| Summary: | summary |