The following data is part of a premarket notification filed by Life Technologies, Inc. with the FDA for Modified Human Tubal Fluid (mhtf) With/without Penicillin G Dolium, With/without Streptomycin Sulfate.
| Device ID | K951835 |
| 510k Number | K951835 |
| Device Name: | MODIFIED HUMAN TUBAL FLUID (MHTF) WITH/WITHOUT PENICILLIN G DOLIUM, WITH/WITHOUT STREPTOMYCIN SULFATE |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | LIFE TECHNOLOGIES, INC. 3175 STALEY RD. P. O. BOX 68 Grand Island, NY 14072 |
| Contact | Keith D Gittermann |
| Correspondent | Keith D Gittermann LIFE TECHNOLOGIES, INC. 3175 STALEY RD. P. O. BOX 68 Grand Island, NY 14072 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-20 |
| Decision Date | 1995-08-11 |