The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Ams Foreign Body Extrator.
| Device ID | K972091 |
| 510k Number | K972091 |
| Device Name: | AMS FOREIGN BODY EXTRATOR |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Lisa L Pritchard |
| Correspondent | Lisa L Pritchard AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-04 |
| Decision Date | 1997-08-29 |
| Summary: | summary |