The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Cavropump.
Device ID | K871129 |
510k Number | K871129 |
Device Name: | CAVROPUMP |
Classification | Device, Erectile Dysfunction |
Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Contact | Coats, Md |
Correspondent | Coats, Md 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 | 1987-03-20 |
Decision Date | 1987-08-28 |