The following data is part of a premarket notification filed by Concept, Inc. with the FDA for C-flo Suction Tube.
Device ID | K882121 |
510k Number | K882121 |
Device Name: | C-FLO SUCTION TUBE |
Classification | Blood Pressure Cuff |
Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Contact | Martha C Miller |
Correspondent | Martha C Miller CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-19 |
Decision Date | 1988-06-20 |