The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for 1/2 Cm Rear Tip Extender (rte).
| Device ID | K882297 |
| 510k Number | K882297 |
| Device Name: | 1/2 CM REAR TIP EXTENDER (RTE) |
| Classification | Ligator, Hemorrhoidal |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Contact | Dennis Toussaint |
| Correspondent | Dennis Toussaint AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-02 |
| Decision Date | 1988-06-17 |