The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Distilled Water.
| Device ID | K923651 |
| 510k Number | K923651 |
| Device Name: | DISTILLED WATER |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Garu J Sfeir |
| Correspondent | Garu J Sfeir LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1993-09-07 |