The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Maintenace Flow - Accesory Device For Cavropump.
Device ID | K903494 |
510k Number | K903494 |
Device Name: | MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP |
Classification | Device, Erectile Dysfunction |
Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Contact | Alfred C Coats |
Correspondent | Alfred C Coats LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Product Code | LST |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-03 |
Decision Date | 1990-10-17 |