The following data is part of a premarket notification filed by Moore/gobel with the FDA for Suction Tip Cleaner Cup.
Device ID | K952219 |
510k Number | K952219 |
Device Name: | SUCTION TIP CLEANER CUP |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | MOORE/GOBEL 9712 SOUTH ALTAMONT DR. Sandy, UT 84092 |
Contact | William E Mckay |
Correspondent | William E Mckay MOORE/GOBEL 9712 SOUTH ALTAMONT DR. Sandy, UT 84092 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-11 |
Decision Date | 1995-11-15 |