The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Urolab Spectrum.
Device ID | K931179 |
510k Number | K931179 |
Device Name: | UROLAB SPECTRUM |
Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Contact | Alfred Coats |
Correspondent | Alfred Coats LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Product Code | FAP |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-09 |
Decision Date | 1993-11-18 |