The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Complete Human Tubal Fluid (htf) With Serum Substitute Supplement, Model 9922.
| Device ID | K003278 |
| 510k Number | K003278 |
| Device Name: | COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922 |
| Classification | Media, Reproductive |
| Applicant | IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Wendell Lee |
| Correspondent | Wendell Lee IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-19 |
| Decision Date | 2001-01-17 |