The following data is part of a premarket notification filed by Leocor, Inc. with the FDA for Leocor Corflo Pump -- Modification.
Device ID | K924110 |
510k Number | K924110 |
Device Name: | LEOCOR CORFLO PUMP -- MODIFICATION |
Classification | Withdrawal/infusion Pump |
Applicant | LEOCOR, INC. 1301 REGENTS PK. DR. Houston, TX 77058 |
Contact | Roger W Snyder |
Correspondent | Roger W Snyder LEOCOR, INC. 1301 REGENTS PK. DR. Houston, TX 77058 |
Product Code | DQI |
CFR Regulation Number | 870.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-03 |
Decision Date | 1992-09-01 |