The following data is part of a premarket notification filed by Select Medical Systems, Inc. with the FDA for Selectcells(tm) Mini.
| Device ID | K974819 |
| 510k Number | K974819 |
| Device Name: | SELECTCELLS(TM) MINI |
| Classification | Curette, Suction, Endometrial (and Accessories) |
| Applicant | SELECT MEDICAL SYSTEMS, INC. 2 WINTERSPORT LN. Williston, VT 05495 |
| Contact | Monique Girard |
| Correspondent | Monique Girard SELECT MEDICAL SYSTEMS, INC. 2 WINTERSPORT LN. Williston, VT 05495 |
| Product Code | HHK |
| CFR Regulation Number | 884.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-23 |
| Decision Date | 1998-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60888937003620 | K974819 | 000 |