The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model 1858 Cavro/pressure Module.
| Device ID | K872077 |
| 510k Number | K872077 |
| Device Name: | MODEL 1858 CAVRO/PRESSURE MODULE |
| Classification | Device, Erectile Dysfunction |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Alfred C Coats,m.d. |
| Correspondent | Alfred C Coats,m.d. 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 | 1987-05-29 |
| Decision Date | 1987-08-27 |