The following data is part of a premarket notification filed by Kirwan Surgical Products, Inc. with the FDA for Endometrial Sampler.
| Device ID | K901896 |
| 510k Number | K901896 |
| Device Name: | ENDOMETRIAL SAMPLER |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Contact | Kirwan, Jr. |
| Correspondent | Kirwan, Jr. KIRWAN SURGICAL PRODUCTS, INC. 83 E. WATER ST. P.O. BOX 545 Rockland, MA 02370 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-25 |
| Decision Date | 1990-08-13 |