The following data is part of a premarket notification filed by Medscand (usa), Inc. with the FDA for Medscand Endorette Endometrial Sampler.
| Device ID | K952652 |
| 510k Number | K952652 |
| Device Name: | MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | MEDSCAND (USA), INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Contact | Tenny P Tse |
| Correspondent | Tenny P Tse MEDSCAND (USA), INC. P.O. BOX 7733 Hollywood, FL 33081 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-09 |
| Decision Date | 1995-09-15 |