The following data is part of a premarket notification filed by Select Medical Systems, Inc. with the FDA for Selectmucus.
| Device ID | K954102 |
| 510k Number | K954102 |
| Device Name: | SELECTMUCUS |
| Classification | Aspirator, Endocervical |
| 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 | HFC |
| CFR Regulation Number | 884.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-31 |
| Decision Date | 1995-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937011238 | K954102 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SELECTMUCUS 74580015 2034199 Live/Registered |
COOPERSURGICAL, INC. 1994-09-29 |