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 |